19002 lines
608 KiB
JSON
19002 lines
608 KiB
JSON
[
|
|
{
|
|
"reportCode": "SIM-2024-000001",
|
|
"occurrenceDate": "2025-03-15",
|
|
"registrationDate": "2025-03-19",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进209621776",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "C6118787",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-03-25",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
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"saeLifeThreatening": false,
|
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"saeDisability": false,
|
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"saeHospitalization": false
|
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},
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{
|
|
"reportCode": "SIM-2024-000002",
|
|
"occurrenceDate": "2025-10-12",
|
|
"registrationDate": "2025-10-16",
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|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205476036",
|
|
"model": "HD-180",
|
|
"batchNo": "G9057869",
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|
"injuryExpression": "透析中低血压",
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|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2025-10-22",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
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"saeLifeThreatening": false,
|
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"saeDisability": false,
|
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"saeHospitalization": false
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},
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{
|
|
"reportCode": "SIM-2024-000003",
|
|
"occurrenceDate": "2024-08-10",
|
|
"registrationDate": "2024-08-22",
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|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进2019269202",
|
|
"model": "EN-SET-1.2",
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|
"batchNo": "G5982691",
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|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
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"saeHospitalization": false
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},
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{
|
|
"reportCode": "SIM-2024-000004",
|
|
"occurrenceDate": "2025-11-27",
|
|
"registrationDate": "2025-12-02",
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|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准207104204",
|
|
"model": "ACID-8L",
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|
"batchNo": "C7618651",
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|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-12-09",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000005",
|
|
"occurrenceDate": "2024-08-12",
|
|
"registrationDate": "2024-08-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进207163910",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E7028011",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-08-20",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000006",
|
|
"occurrenceDate": "2024-11-05",
|
|
"registrationDate": "2024-11-12",
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|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207981296",
|
|
"model": "IS-7.0",
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|
"batchNo": "D5605540",
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|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-11-15",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000007",
|
|
"occurrenceDate": "2024-12-24",
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|
"registrationDate": "2024-12-31",
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"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2016242804",
|
|
"model": "ACID-8L",
|
|
"batchNo": "G8096064",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-01-03",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000008",
|
|
"occurrenceDate": "2024-12-05",
|
|
"registrationDate": "2024-12-06",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205318775",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J1177507",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2024-12-09",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
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|
},
|
|
{
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|
"reportCode": "SIM-2024-000009",
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"occurrenceDate": "2025-01-11",
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"registrationDate": "2025-01-16",
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"unitName": "天津市肿瘤医院",
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|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019357330",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "D6643078",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-01-23",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000010",
|
|
"occurrenceDate": "2025-08-03",
|
|
"registrationDate": "2025-08-07",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2017526731",
|
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"model": "Introcan 18G",
|
|
"batchNo": "D4982844",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2025-08-13",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000011",
|
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"occurrenceDate": "2024-02-19",
|
|
"registrationDate": "2024-02-23",
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|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进208282818",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "G3604382",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2024-02-29",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000012",
|
|
"occurrenceDate": "2024-12-21",
|
|
"registrationDate": "2024-12-23",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019249678",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J7320772",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-12-27",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000013",
|
|
"occurrenceDate": "2025-02-19",
|
|
"registrationDate": "2025-02-22",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进206470445",
|
|
"model": "EX-100cm",
|
|
"batchNo": "B5285088",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-02-27",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000014",
|
|
"occurrenceDate": "2025-03-03",
|
|
"registrationDate": "2025-03-04",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2016344325",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "E2973487",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2025-03-07",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000015",
|
|
"occurrenceDate": "2025-03-28",
|
|
"registrationDate": "2025-04-05",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2015498766",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "B8593095",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2025-04-09",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000016",
|
|
"occurrenceDate": "2026-03-02",
|
|
"registrationDate": "2026-03-03",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2018160440",
|
|
"model": "ACID-8L",
|
|
"batchNo": "G2685828",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-03-06",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000017",
|
|
"occurrenceDate": "2025-05-28",
|
|
"registrationDate": "2025-06-07",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016811641",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F4312061",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-06-13",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000018",
|
|
"occurrenceDate": "2026-02-20",
|
|
"registrationDate": "2026-02-22",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进209771195",
|
|
"model": "BIC-35",
|
|
"batchNo": "G4089158",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-02-26",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000019",
|
|
"occurrenceDate": "2024-01-22",
|
|
"registrationDate": "2024-01-29",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208783287",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H4396266",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-02-01",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000020",
|
|
"occurrenceDate": "2026-03-23",
|
|
"registrationDate": "2026-03-24",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2018596134",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "J4289294",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2026-03-27",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000021",
|
|
"occurrenceDate": "2025-12-28",
|
|
"registrationDate": "2026-01-04",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准209245459",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "H8810907",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2026-01-07",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000022",
|
|
"occurrenceDate": "2025-04-15",
|
|
"registrationDate": "2025-04-19",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209704183",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "B7059004",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2025-04-25",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000023",
|
|
"occurrenceDate": "2025-09-07",
|
|
"registrationDate": "2025-09-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2016210129",
|
|
"model": "EX-50cm",
|
|
"batchNo": "D9349686",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-09-19",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000024",
|
|
"occurrenceDate": "2026-03-29",
|
|
"registrationDate": "2026-03-30",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准205663526",
|
|
"model": "EX-50cm",
|
|
"batchNo": "D1145603",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2026-04-02",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000025",
|
|
"occurrenceDate": "2025-10-09",
|
|
"registrationDate": "2025-10-18",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2019973770",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "E4068217",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2025-10-23",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000026",
|
|
"occurrenceDate": "2025-08-29",
|
|
"registrationDate": "2025-09-04",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209437366",
|
|
"model": "4251624",
|
|
"batchNo": "H5284533",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-09-12",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000027",
|
|
"occurrenceDate": "2024-03-29",
|
|
"registrationDate": "2024-04-07",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准207640543",
|
|
"model": "4251624",
|
|
"batchNo": "C4103074",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-04-12",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000028",
|
|
"occurrenceDate": "2026-02-28",
|
|
"registrationDate": "2026-03-08",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2017612057",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "F3410499",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2026-03-12",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000029",
|
|
"occurrenceDate": "2024-07-31",
|
|
"registrationDate": "2024-08-10",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017444567",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H3898036",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2024-08-16",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000030",
|
|
"occurrenceDate": "2024-11-09",
|
|
"registrationDate": "2024-11-11",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2018340683",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "C3534391",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-11-15",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000031",
|
|
"occurrenceDate": "2025-10-16",
|
|
"registrationDate": "2025-10-28",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207706520",
|
|
"model": "4251625",
|
|
"batchNo": "B2231351",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-11-05",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000032",
|
|
"occurrenceDate": "2023-12-18",
|
|
"registrationDate": "2023-12-22",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017842902",
|
|
"model": "4251625",
|
|
"batchNo": "C3881664",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2023-12-28",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000033",
|
|
"occurrenceDate": "2025-09-12",
|
|
"registrationDate": "2025-09-18",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016503509",
|
|
"model": "IS-7.0",
|
|
"batchNo": "K7720117",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-09-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000034",
|
|
"occurrenceDate": "2024-07-31",
|
|
"registrationDate": "2024-08-08",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206695409",
|
|
"model": "EX-50cm",
|
|
"batchNo": "A2076649",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-08-12",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000035",
|
|
"occurrenceDate": "2024-04-19",
|
|
"registrationDate": "2024-04-25",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208685352",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "F7290522",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-05-03",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000036",
|
|
"occurrenceDate": "2025-11-18",
|
|
"registrationDate": "2025-11-21",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2019423577",
|
|
"model": "ACID-8L",
|
|
"batchNo": "B3298278",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-11-26",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000037",
|
|
"occurrenceDate": "2025-05-07",
|
|
"registrationDate": "2025-05-15",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016674933",
|
|
"model": "4251625",
|
|
"batchNo": "C5101117",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-05-19",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000038",
|
|
"occurrenceDate": "2025-07-05",
|
|
"registrationDate": "2025-07-13",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进205738239",
|
|
"model": "4251625",
|
|
"batchNo": "H1456492",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-07-17",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000039",
|
|
"occurrenceDate": "2024-02-02",
|
|
"registrationDate": "2024-02-10",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018585405",
|
|
"model": "IS-7.0",
|
|
"batchNo": "D7139777",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-02-14",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000040",
|
|
"occurrenceDate": "2024-08-09",
|
|
"registrationDate": "2024-08-16",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015396618",
|
|
"model": "PF-5.0",
|
|
"batchNo": "K2568433",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-08-19",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000041",
|
|
"occurrenceDate": "2025-09-28",
|
|
"registrationDate": "2025-10-03",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206218794",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "B8806759",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-10-10",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000042",
|
|
"occurrenceDate": "2025-10-13",
|
|
"registrationDate": "2025-10-24",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2015645765",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "J4570115",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2025-10-31",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000043",
|
|
"occurrenceDate": "2025-03-02",
|
|
"registrationDate": "2025-03-03",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019146848",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C5233842",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-03-06",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000044",
|
|
"occurrenceDate": "2025-11-21",
|
|
"registrationDate": "2025-11-25",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2015124576",
|
|
"model": "4251625",
|
|
"batchNo": "H9105083",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2025-12-01",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000045",
|
|
"occurrenceDate": "2024-08-24",
|
|
"registrationDate": "2024-09-03",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206771344",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C8783009",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-09-09",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000046",
|
|
"occurrenceDate": "2025-02-01",
|
|
"registrationDate": "2025-02-03",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进209386383",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "F3441661",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-02-07",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000047",
|
|
"occurrenceDate": "2025-06-21",
|
|
"registrationDate": "2025-06-23",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209632427",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F4666993",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-06-27",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000048",
|
|
"occurrenceDate": "2024-09-02",
|
|
"registrationDate": "2024-09-09",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进209620993",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "D4369730",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-09-12",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000049",
|
|
"occurrenceDate": "2024-06-17",
|
|
"registrationDate": "2024-06-28",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207613049",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H9333815",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-07-05",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000050",
|
|
"occurrenceDate": "2024-11-10",
|
|
"registrationDate": "2024-11-18",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准206986870",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J2701309",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-11-22",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000051",
|
|
"occurrenceDate": "2025-01-06",
|
|
"registrationDate": "2025-01-15",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015602381",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "G2771273",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-01-20",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000052",
|
|
"occurrenceDate": "2025-03-07",
|
|
"registrationDate": "2025-03-11",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准208779726",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "C2374074",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2025-03-17",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000053",
|
|
"occurrenceDate": "2025-06-11",
|
|
"registrationDate": "2025-06-21",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207893693",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "G8165558",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-06-27",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000054",
|
|
"occurrenceDate": "2024-01-09",
|
|
"registrationDate": "2024-01-15",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019996252",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "C2309689",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-01-23",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000055",
|
|
"occurrenceDate": "2024-08-29",
|
|
"registrationDate": "2024-09-03",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准209253501",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "E1157175",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-09-10",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000056",
|
|
"occurrenceDate": "2023-12-15",
|
|
"registrationDate": "2023-12-26",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2017143768",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C4784736",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-01-02",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000057",
|
|
"occurrenceDate": "2025-08-20",
|
|
"registrationDate": "2025-08-30",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209183497",
|
|
"model": "IS-5.0",
|
|
"batchNo": "B1116664",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-09-05",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000058",
|
|
"occurrenceDate": "2025-02-14",
|
|
"registrationDate": "2025-02-22",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2016767382",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E9471543",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-02-26",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000059",
|
|
"occurrenceDate": "2025-07-29",
|
|
"registrationDate": "2025-08-02",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2016818373",
|
|
"model": "ACID-8L",
|
|
"batchNo": "K5874967",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-08-08",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000060",
|
|
"occurrenceDate": "2025-04-12",
|
|
"registrationDate": "2025-04-24",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018901592",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A6253350",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-05-02",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000061",
|
|
"occurrenceDate": "2024-08-29",
|
|
"registrationDate": "2024-09-07",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准207940763",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "B5963979",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-09-12",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000062",
|
|
"occurrenceDate": "2024-11-11",
|
|
"registrationDate": "2024-11-15",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2015305062",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "C4592024",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-11-21",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000063",
|
|
"occurrenceDate": "2025-06-13",
|
|
"registrationDate": "2025-06-17",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206620934",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "E3980810",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-06-23",
|
|
"province": "重庆市",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000064",
|
|
"occurrenceDate": "2025-01-01",
|
|
"registrationDate": "2025-01-03",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进208820900",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "J8679655",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-01-07",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000065",
|
|
"occurrenceDate": "2025-10-29",
|
|
"registrationDate": "2025-11-08",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2015385972",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E7525187",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-11-14",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000066",
|
|
"occurrenceDate": "2025-02-09",
|
|
"registrationDate": "2025-02-16",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2015596818",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "E4541844",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-02-19",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000067",
|
|
"occurrenceDate": "2025-03-05",
|
|
"registrationDate": "2025-03-13",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207842639",
|
|
"model": "IS-7.0",
|
|
"batchNo": "D8142732",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-03-17",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000068",
|
|
"occurrenceDate": "2025-12-21",
|
|
"registrationDate": "2025-12-25",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准206752482",
|
|
"model": "PF-7.0",
|
|
"batchNo": "G2259144",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-12-31",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000069",
|
|
"occurrenceDate": "2024-01-01",
|
|
"registrationDate": "2024-01-12",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2018404778",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "A5679318",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-01-19",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000070",
|
|
"occurrenceDate": "2024-03-04",
|
|
"registrationDate": "2024-03-08",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2019164910",
|
|
"model": "EX-50cm",
|
|
"batchNo": "A5117301",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-03-14",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000071",
|
|
"occurrenceDate": "2024-02-25",
|
|
"registrationDate": "2024-03-06",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2015465871",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "F3685734",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-03-12",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000072",
|
|
"occurrenceDate": "2024-01-13",
|
|
"registrationDate": "2024-01-21",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进209967048",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "B7254490",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-01-25",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000073",
|
|
"occurrenceDate": "2024-01-14",
|
|
"registrationDate": "2024-01-22",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准207160248",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "G6052257",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000074",
|
|
"occurrenceDate": "2025-08-08",
|
|
"registrationDate": "2025-08-12",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进205717441",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C9808603",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-08-18",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000075",
|
|
"occurrenceDate": "2024-12-31",
|
|
"registrationDate": "2025-01-04",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018920927",
|
|
"model": "EX-100cm",
|
|
"batchNo": "D7876702",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-01-10",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000076",
|
|
"occurrenceDate": "2025-01-02",
|
|
"registrationDate": "2025-01-07",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2017569782",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "K5160142",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2025-01-14",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000077",
|
|
"occurrenceDate": "2025-11-22",
|
|
"registrationDate": "2025-11-24",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016973120",
|
|
"model": "IS-5.0",
|
|
"batchNo": "K5320096",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-11-28",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000078",
|
|
"occurrenceDate": "2023-12-23",
|
|
"registrationDate": "2024-01-04",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2017476402",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "F7447229",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-01-12",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000079",
|
|
"occurrenceDate": "2024-02-12",
|
|
"registrationDate": "2024-02-13",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016179481",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F6192362",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-02-16",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000080",
|
|
"occurrenceDate": "2024-10-07",
|
|
"registrationDate": "2024-10-10",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206268390",
|
|
"model": "4251625",
|
|
"batchNo": "C2760923",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-10-15",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000081",
|
|
"occurrenceDate": "2025-08-17",
|
|
"registrationDate": "2025-08-22",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2017398947",
|
|
"model": "ACID-8L",
|
|
"batchNo": "G5114580",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-08-29",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000082",
|
|
"occurrenceDate": "2025-03-20",
|
|
"registrationDate": "2025-03-23",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2015387557",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "K1723821",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000083",
|
|
"occurrenceDate": "2024-01-29",
|
|
"registrationDate": "2024-02-05",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018410703",
|
|
"model": "4251625",
|
|
"batchNo": "F7888669",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-02-08",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000084",
|
|
"occurrenceDate": "2024-09-25",
|
|
"registrationDate": "2024-10-07",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207286255",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K3316293",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-10-15",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000085",
|
|
"occurrenceDate": "2025-03-01",
|
|
"registrationDate": "2025-03-03",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205695722",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E8068432",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-03-07",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000086",
|
|
"occurrenceDate": "2024-09-24",
|
|
"registrationDate": "2024-10-01",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208373219",
|
|
"model": "4251624",
|
|
"batchNo": "J1565987",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-10-04",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000087",
|
|
"occurrenceDate": "2024-05-26",
|
|
"registrationDate": "2024-05-29",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207549201",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D8412755",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-06-03",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000088",
|
|
"occurrenceDate": "2024-07-15",
|
|
"registrationDate": "2024-07-24",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208499510",
|
|
"model": "IS-5.0",
|
|
"batchNo": "F1421850",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-07-29",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000089",
|
|
"occurrenceDate": "2025-12-17",
|
|
"registrationDate": "2025-12-27",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进207318216",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "C9204134",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2026-01-02",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000090",
|
|
"occurrenceDate": "2026-02-08",
|
|
"registrationDate": "2026-02-13",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2016311455",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "H5255983",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2026-02-20",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000091",
|
|
"occurrenceDate": "2025-10-21",
|
|
"registrationDate": "2025-10-25",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2016497375",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "F7361745",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-10-31",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000092",
|
|
"occurrenceDate": "2024-03-17",
|
|
"registrationDate": "2024-03-27",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准207945693",
|
|
"model": "PF-7.0",
|
|
"batchNo": "K5938613",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-04-02",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000093",
|
|
"occurrenceDate": "2025-07-11",
|
|
"registrationDate": "2025-07-20",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016600201",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "E6026960",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-07-25",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000094",
|
|
"occurrenceDate": "2024-12-05",
|
|
"registrationDate": "2024-12-06",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015176475",
|
|
"model": "4251624",
|
|
"batchNo": "B7662792",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-12-09",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000095",
|
|
"occurrenceDate": "2024-01-04",
|
|
"registrationDate": "2024-01-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准205339536",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "F8821981",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2024-01-22",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000096",
|
|
"occurrenceDate": "2025-03-08",
|
|
"registrationDate": "2025-03-20",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2018547386",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E7980877",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000097",
|
|
"occurrenceDate": "2024-08-20",
|
|
"registrationDate": "2024-09-01",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015244827",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F5845083",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-09-09",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000098",
|
|
"occurrenceDate": "2024-01-01",
|
|
"registrationDate": "2024-01-04",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206158882",
|
|
"model": "PF-7.0",
|
|
"batchNo": "K9617138",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-01-09",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000099",
|
|
"occurrenceDate": "2025-08-22",
|
|
"registrationDate": "2025-08-31",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208694219",
|
|
"model": "4251624",
|
|
"batchNo": "H9095110",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2025-09-05",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000100",
|
|
"occurrenceDate": "2024-11-28",
|
|
"registrationDate": "2024-11-30",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进209146179",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "C3034931",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-12-04",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000101",
|
|
"occurrenceDate": "2024-08-12",
|
|
"registrationDate": "2024-08-22",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019191936",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E9851402",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-08-28",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000102",
|
|
"occurrenceDate": "2024-01-04",
|
|
"registrationDate": "2024-01-12",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2019269420",
|
|
"model": "4251625",
|
|
"batchNo": "J4121174",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-01-16",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000103",
|
|
"occurrenceDate": "2025-02-10",
|
|
"registrationDate": "2025-02-14",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206406465",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D5895529",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-02-20",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000104",
|
|
"occurrenceDate": "2024-10-14",
|
|
"registrationDate": "2024-10-21",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准206971792",
|
|
"model": "PF-7.0",
|
|
"batchNo": "G6324593",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-10-24",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000105",
|
|
"occurrenceDate": "2025-09-23",
|
|
"registrationDate": "2025-10-03",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205210751",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E3703129",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-10-09",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000106",
|
|
"occurrenceDate": "2025-01-16",
|
|
"registrationDate": "2025-01-17",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准207726632",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "B4342377",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-01-20",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000107",
|
|
"occurrenceDate": "2024-10-05",
|
|
"registrationDate": "2024-10-07",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018841979",
|
|
"model": "4053000",
|
|
"batchNo": "A2701686",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-10-11",
|
|
"province": "云南省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000108",
|
|
"occurrenceDate": "2024-09-29",
|
|
"registrationDate": "2024-10-04",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018160277",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "B2725649",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2024-10-11",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000109",
|
|
"occurrenceDate": "2024-07-27",
|
|
"registrationDate": "2024-08-07",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进2019296456",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "G3366600",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2024-08-14",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000110",
|
|
"occurrenceDate": "2024-08-08",
|
|
"registrationDate": "2024-08-13",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017528857",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F4257880",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-08-20",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000111",
|
|
"occurrenceDate": "2026-03-14",
|
|
"registrationDate": "2026-03-26",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2018302383",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "H3872284",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2026-04-03",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000112",
|
|
"occurrenceDate": "2024-05-10",
|
|
"registrationDate": "2024-05-16",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015938400",
|
|
"model": "PF-7.0",
|
|
"batchNo": "G6808519",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000113",
|
|
"occurrenceDate": "2024-04-29",
|
|
"registrationDate": "2024-04-30",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206396412",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E7768104",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-05-03",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000114",
|
|
"occurrenceDate": "2026-02-01",
|
|
"registrationDate": "2026-02-09",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018947451",
|
|
"model": "4053000",
|
|
"batchNo": "H6286784",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2026-02-13",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000115",
|
|
"occurrenceDate": "2025-04-03",
|
|
"registrationDate": "2025-04-08",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2015696000",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A4911203",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2025-04-15",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000116",
|
|
"occurrenceDate": "2024-10-28",
|
|
"registrationDate": "2024-11-04",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2015265560",
|
|
"model": "10ml Luer",
|
|
"batchNo": "C4648901",
|
|
"injuryExpression": "给药剂量偏差相关不适",
|
|
"deviceFailure": "刻度印刷模糊",
|
|
"reviewDate": "2024-11-07",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000117",
|
|
"occurrenceDate": "2024-11-12",
|
|
"registrationDate": "2024-11-16",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016322625",
|
|
"model": "4251625",
|
|
"batchNo": "C9080623",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-11-22",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000118",
|
|
"occurrenceDate": "2025-10-02",
|
|
"registrationDate": "2025-10-10",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208434009",
|
|
"model": "4251625",
|
|
"batchNo": "J4122975",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-10-14",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000119",
|
|
"occurrenceDate": "2024-01-26",
|
|
"registrationDate": "2024-01-28",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准205514106",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "A6028711",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-02-01",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000120",
|
|
"occurrenceDate": "2025-02-17",
|
|
"registrationDate": "2025-02-23",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205489727",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "E1032153",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-03-03",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000121",
|
|
"occurrenceDate": "2026-02-05",
|
|
"registrationDate": "2026-02-10",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2016217912",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C5121372",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2026-02-17",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000122",
|
|
"occurrenceDate": "2024-05-16",
|
|
"registrationDate": "2024-05-19",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2015652241",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A9396025",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000123",
|
|
"occurrenceDate": "2024-07-11",
|
|
"registrationDate": "2024-07-17",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2019889262",
|
|
"model": "IS-5.0",
|
|
"batchNo": "A6407816",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-07-25",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000124",
|
|
"occurrenceDate": "2024-02-27",
|
|
"registrationDate": "2024-03-07",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2015791256",
|
|
"model": "EX-50cm",
|
|
"batchNo": "A1427602",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-03-12",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000125",
|
|
"occurrenceDate": "2024-09-30",
|
|
"registrationDate": "2024-10-11",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207539502",
|
|
"model": "4251624",
|
|
"batchNo": "F8605862",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-10-18",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000126",
|
|
"occurrenceDate": "2024-06-14",
|
|
"registrationDate": "2024-06-26",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2018390997",
|
|
"model": "ACID-8L",
|
|
"batchNo": "H9408374",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-07-04",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000127",
|
|
"occurrenceDate": "2025-04-15",
|
|
"registrationDate": "2025-04-18",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206271486",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "G5772441",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-04-23",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000128",
|
|
"occurrenceDate": "2025-07-26",
|
|
"registrationDate": "2025-08-06",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准206674632",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "C3156967",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2025-08-13",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000129",
|
|
"occurrenceDate": "2024-10-26",
|
|
"registrationDate": "2024-10-28",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207810937",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E3993714",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-11-01",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000130",
|
|
"occurrenceDate": "2024-05-23",
|
|
"registrationDate": "2024-06-03",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207771429",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E6449474",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-06-10",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000131",
|
|
"occurrenceDate": "2024-01-12",
|
|
"registrationDate": "2024-01-23",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2018953418",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "C9155978",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-01-30",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000132",
|
|
"occurrenceDate": "2024-02-22",
|
|
"registrationDate": "2024-03-05",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2015545814",
|
|
"model": "HD-180",
|
|
"batchNo": "B8538049",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-03-13",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000133",
|
|
"occurrenceDate": "2024-08-08",
|
|
"registrationDate": "2024-08-09",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准209968636",
|
|
"model": "IS-5.0",
|
|
"batchNo": "G8847876",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-08-12",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000134",
|
|
"occurrenceDate": "2025-10-18",
|
|
"registrationDate": "2025-10-26",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准205790869",
|
|
"model": "EX-50cm",
|
|
"batchNo": "F4811787",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-10-30",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000135",
|
|
"occurrenceDate": "2024-11-21",
|
|
"registrationDate": "2024-11-24",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207455775",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H3231958",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-11-29",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000136",
|
|
"occurrenceDate": "2023-12-18",
|
|
"registrationDate": "2023-12-19",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2018539855",
|
|
"model": "BIC-35",
|
|
"batchNo": "H9151154",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2023-12-22",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000137",
|
|
"occurrenceDate": "2025-03-10",
|
|
"registrationDate": "2025-03-19",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205710516",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J7062463",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-03-24",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000138",
|
|
"occurrenceDate": "2023-12-15",
|
|
"registrationDate": "2023-12-17",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019969269",
|
|
"model": "IS-5.0",
|
|
"batchNo": "A7511763",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2023-12-21",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000139",
|
|
"occurrenceDate": "2024-07-04",
|
|
"registrationDate": "2024-07-13",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准205778832",
|
|
"model": "PF-5.0",
|
|
"batchNo": "B7537298",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-07-18",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000140",
|
|
"occurrenceDate": "2024-09-30",
|
|
"registrationDate": "2024-10-06",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2015881139",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "J8738522",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-10-14",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000141",
|
|
"occurrenceDate": "2024-08-28",
|
|
"registrationDate": "2024-08-31",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进207702269",
|
|
"model": "PF-7.0",
|
|
"batchNo": "H2891531",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-09-05",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000142",
|
|
"occurrenceDate": "2024-02-28",
|
|
"registrationDate": "2024-03-02",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205938743",
|
|
"model": "4053000",
|
|
"batchNo": "A3116269",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-03-07",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000143",
|
|
"occurrenceDate": "2025-03-05",
|
|
"registrationDate": "2025-03-17",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2015762699",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "J4664575",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2025-03-25",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000144",
|
|
"occurrenceDate": "2025-07-01",
|
|
"registrationDate": "2025-07-05",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2015340642",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E3085023",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000145",
|
|
"occurrenceDate": "2024-02-20",
|
|
"registrationDate": "2024-03-03",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准206816361",
|
|
"model": "20ml Luer",
|
|
"batchNo": "B4174451",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2024-03-11",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000146",
|
|
"occurrenceDate": "2024-06-14",
|
|
"registrationDate": "2024-06-16",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2018803823",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "F6278861",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-06-20",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000147",
|
|
"occurrenceDate": "2024-12-26",
|
|
"registrationDate": "2024-12-28",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2015140359",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "E5174528",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2025-01-01",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000148",
|
|
"occurrenceDate": "2024-07-24",
|
|
"registrationDate": "2024-08-03",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2015632919",
|
|
"model": "10ml Luer",
|
|
"batchNo": "A9574949",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2024-08-09",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000149",
|
|
"occurrenceDate": "2024-09-17",
|
|
"registrationDate": "2024-09-20",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018375611",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C4785796",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-09-25",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000150",
|
|
"occurrenceDate": "2025-06-08",
|
|
"registrationDate": "2025-06-16",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207754965",
|
|
"model": "IS-7.0",
|
|
"batchNo": "K5317805",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-06-20",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000151",
|
|
"occurrenceDate": "2025-01-21",
|
|
"registrationDate": "2025-01-25",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准205629382",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "G8000388",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-01-31",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000152",
|
|
"occurrenceDate": "2025-12-14",
|
|
"registrationDate": "2025-12-17",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准206582613",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K9230345",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-12-22",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000153",
|
|
"occurrenceDate": "2024-06-05",
|
|
"registrationDate": "2024-06-11",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2015519946",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K3756880",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-06-19",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000154",
|
|
"occurrenceDate": "2026-01-17",
|
|
"registrationDate": "2026-01-24",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准209918235",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "A6007214",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2026-01-27",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000155",
|
|
"occurrenceDate": "2025-10-18",
|
|
"registrationDate": "2025-10-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准205938887",
|
|
"model": "EX-100cm",
|
|
"batchNo": "A6404716",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-10-30",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000156",
|
|
"occurrenceDate": "2025-07-20",
|
|
"registrationDate": "2025-07-24",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准207265356",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "J1353836",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-07-30",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000157",
|
|
"occurrenceDate": "2025-09-15",
|
|
"registrationDate": "2025-09-26",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2016140351",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "D2168026",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-10-03",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000158",
|
|
"occurrenceDate": "2025-06-18",
|
|
"registrationDate": "2025-06-28",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进208636613",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "C3593614",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2025-07-04",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000159",
|
|
"occurrenceDate": "2025-08-18",
|
|
"registrationDate": "2025-08-24",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206983475",
|
|
"model": "IS-7.0",
|
|
"batchNo": "C3291368",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-09-01",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000160",
|
|
"occurrenceDate": "2026-03-26",
|
|
"registrationDate": "2026-03-28",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208281475",
|
|
"model": "HD-180",
|
|
"batchNo": "H9572290",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2026-04-01",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000161",
|
|
"occurrenceDate": "2025-02-26",
|
|
"registrationDate": "2025-03-08",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2019873316",
|
|
"model": "4251625",
|
|
"batchNo": "E2514857",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-03-14",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000162",
|
|
"occurrenceDate": "2025-07-25",
|
|
"registrationDate": "2025-07-27",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207776836",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "D1898032",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-07-31",
|
|
"province": "上海市",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000163",
|
|
"occurrenceDate": "2024-11-07",
|
|
"registrationDate": "2024-11-10",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准207457787",
|
|
"model": "PF-7.0",
|
|
"batchNo": "B4775882",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-11-15",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000164",
|
|
"occurrenceDate": "2025-06-02",
|
|
"registrationDate": "2025-06-03",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2017745696",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "B4969051",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-06-06",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000165",
|
|
"occurrenceDate": "2024-05-02",
|
|
"registrationDate": "2024-05-13",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进208173373",
|
|
"model": "EX-100cm",
|
|
"batchNo": "F2430774",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-05-20",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000166",
|
|
"occurrenceDate": "2025-03-30",
|
|
"registrationDate": "2025-04-03",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205955338",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "H3994527",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2025-04-09",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000167",
|
|
"occurrenceDate": "2024-08-30",
|
|
"registrationDate": "2024-09-04",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进208793667",
|
|
"model": "EX-50cm",
|
|
"batchNo": "E7290465",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-09-11",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000168",
|
|
"occurrenceDate": "2024-05-19",
|
|
"registrationDate": "2024-05-24",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准208282343",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "A8683642",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-05-31",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000169",
|
|
"occurrenceDate": "2023-12-12",
|
|
"registrationDate": "2023-12-19",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2017449432",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "J8249874",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2023-12-22",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000170",
|
|
"occurrenceDate": "2025-11-03",
|
|
"registrationDate": "2025-11-14",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准205574081",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "K1037465",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-11-21",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000171",
|
|
"occurrenceDate": "2025-12-05",
|
|
"registrationDate": "2025-12-09",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207363561",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "D4512594",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-12-15",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000172",
|
|
"occurrenceDate": "2025-01-11",
|
|
"registrationDate": "2025-01-13",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2015241648",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "D4512594",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-01-17",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000173",
|
|
"occurrenceDate": "2024-01-26",
|
|
"registrationDate": "2024-01-31",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205307453",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F7321089",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-02-07",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000174",
|
|
"occurrenceDate": "2025-12-02",
|
|
"registrationDate": "2025-12-12",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016673673",
|
|
"model": "4251624",
|
|
"batchNo": "H8006848",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-12-18",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000175",
|
|
"occurrenceDate": "2024-04-05",
|
|
"registrationDate": "2024-04-11",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进208569574",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D2329650",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-04-19",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000176",
|
|
"occurrenceDate": "2024-06-28",
|
|
"registrationDate": "2024-07-04",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2019908109",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "D6103402",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2024-07-12",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000177",
|
|
"occurrenceDate": "2024-08-15",
|
|
"registrationDate": "2024-08-23",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进209512327",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "B3918410",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-08-27",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000178",
|
|
"occurrenceDate": "2025-06-13",
|
|
"registrationDate": "2025-06-24",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209493509",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "H1061990",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2025-07-01",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000179",
|
|
"occurrenceDate": "2026-02-14",
|
|
"registrationDate": "2026-02-16",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2018910018",
|
|
"model": "BIC-35",
|
|
"batchNo": "E3988138",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-02-20",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000180",
|
|
"occurrenceDate": "2024-10-17",
|
|
"registrationDate": "2024-10-19",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208499492",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "G7658475",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-10-23",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000181",
|
|
"occurrenceDate": "2024-12-30",
|
|
"registrationDate": "2025-01-05",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进208990617",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "B4776166",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-01-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000182",
|
|
"occurrenceDate": "2026-01-09",
|
|
"registrationDate": "2026-01-17",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207206223",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "C4124818",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2026-01-21",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000183",
|
|
"occurrenceDate": "2026-02-27",
|
|
"registrationDate": "2026-03-05",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2019690352",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "J5782278",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2026-03-13",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000184",
|
|
"occurrenceDate": "2024-07-29",
|
|
"registrationDate": "2024-08-09",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2018872870",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "B4536551",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-08-16",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000185",
|
|
"occurrenceDate": "2023-11-30",
|
|
"registrationDate": "2023-12-11",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进208376782",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J9557838",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2023-12-18",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000186",
|
|
"occurrenceDate": "2024-10-10",
|
|
"registrationDate": "2024-10-18",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205415258",
|
|
"model": "HD-180",
|
|
"batchNo": "H6024622",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-10-22",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000187",
|
|
"occurrenceDate": "2024-03-01",
|
|
"registrationDate": "2024-03-07",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2018514617",
|
|
"model": "BIC-35",
|
|
"batchNo": "E4247873",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2024-03-15",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000188",
|
|
"occurrenceDate": "2026-02-10",
|
|
"registrationDate": "2026-02-13",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准206701960",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D4921080",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2026-02-18",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000189",
|
|
"occurrenceDate": "2026-03-15",
|
|
"registrationDate": "2026-03-23",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205178774",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "K5683239",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2026-03-27",
|
|
"province": "江苏省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000190",
|
|
"occurrenceDate": "2025-12-31",
|
|
"registrationDate": "2026-01-08",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207738182",
|
|
"model": "HD-180",
|
|
"batchNo": "F5395676",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2026-01-12",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000191",
|
|
"occurrenceDate": "2025-11-25",
|
|
"registrationDate": "2025-12-07",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019884116",
|
|
"model": "IS-7.0",
|
|
"batchNo": "C5930679",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-12-15",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000192",
|
|
"occurrenceDate": "2024-02-06",
|
|
"registrationDate": "2024-02-18",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019544944",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "D4272881",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-02-26",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000193",
|
|
"occurrenceDate": "2025-07-07",
|
|
"registrationDate": "2025-07-18",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2016271923",
|
|
"model": "EX-100cm",
|
|
"batchNo": "F7366284",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-07-25",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000194",
|
|
"occurrenceDate": "2025-06-05",
|
|
"registrationDate": "2025-06-06",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进206179569",
|
|
"model": "EX-100cm",
|
|
"batchNo": "K1556850",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-06-09",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000195",
|
|
"occurrenceDate": "2025-11-23",
|
|
"registrationDate": "2025-11-28",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进208145892",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "K2832018",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2025-12-05",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000196",
|
|
"occurrenceDate": "2024-01-07",
|
|
"registrationDate": "2024-01-12",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206210196",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "J7504082",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2024-01-19",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000197",
|
|
"occurrenceDate": "2025-07-05",
|
|
"registrationDate": "2025-07-16",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准206463428",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "H7515587",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-07-23",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000198",
|
|
"occurrenceDate": "2026-01-28",
|
|
"registrationDate": "2026-02-07",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进209914119",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "A9485094",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2026-02-13",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000199",
|
|
"occurrenceDate": "2025-12-23",
|
|
"registrationDate": "2025-12-27",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2015404136",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H1101479",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2026-01-02",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000200",
|
|
"occurrenceDate": "2025-09-12",
|
|
"registrationDate": "2025-09-18",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015448188",
|
|
"model": "4053000",
|
|
"batchNo": "J8997517",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-09-26",
|
|
"province": "江苏省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000201",
|
|
"occurrenceDate": "2024-03-31",
|
|
"registrationDate": "2024-04-08",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206368896",
|
|
"model": "4251624",
|
|
"batchNo": "G5272317",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-04-12",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000202",
|
|
"occurrenceDate": "2024-05-25",
|
|
"registrationDate": "2024-06-04",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进209390522",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E8221834",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-06-10",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000203",
|
|
"occurrenceDate": "2025-05-10",
|
|
"registrationDate": "2025-05-12",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018774049",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "H3949948",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-05-16",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000204",
|
|
"occurrenceDate": "2025-10-11",
|
|
"registrationDate": "2025-10-15",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进208148859",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "B2437575",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2025-10-21",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000205",
|
|
"occurrenceDate": "2023-12-24",
|
|
"registrationDate": "2024-01-01",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017621558",
|
|
"model": "4053000",
|
|
"batchNo": "A5310178",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-01-05",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000206",
|
|
"occurrenceDate": "2024-09-10",
|
|
"registrationDate": "2024-09-14",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016936939",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A5310178",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000207",
|
|
"occurrenceDate": "2024-03-10",
|
|
"registrationDate": "2024-03-21",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2019622531",
|
|
"model": "PF-7.0",
|
|
"batchNo": "A9590964",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-03-28",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000208",
|
|
"occurrenceDate": "2024-09-21",
|
|
"registrationDate": "2024-09-23",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2016252310",
|
|
"model": "EX-100cm",
|
|
"batchNo": "G5982222",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-09-27",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000209",
|
|
"occurrenceDate": "2025-11-12",
|
|
"registrationDate": "2025-11-20",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2016621065",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "E3480323",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-11-24",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000210",
|
|
"occurrenceDate": "2024-03-12",
|
|
"registrationDate": "2024-03-16",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准206359518",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "D3618381",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2024-03-22",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000211",
|
|
"occurrenceDate": "2025-09-13",
|
|
"registrationDate": "2025-09-14",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209999268",
|
|
"model": "4053000",
|
|
"batchNo": "D8306097",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-09-17",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000212",
|
|
"occurrenceDate": "2025-11-11",
|
|
"registrationDate": "2025-11-18",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2017388304",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "F8168904",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-11-21",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000213",
|
|
"occurrenceDate": "2024-03-10",
|
|
"registrationDate": "2024-03-14",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015818467",
|
|
"model": "PF-7.0",
|
|
"batchNo": "H8524215",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2024-03-20",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000214",
|
|
"occurrenceDate": "2025-06-03",
|
|
"registrationDate": "2025-06-15",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2017429385",
|
|
"model": "PF-7.0",
|
|
"batchNo": "H4493569",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-06-23",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000215",
|
|
"occurrenceDate": "2024-04-19",
|
|
"registrationDate": "2024-04-27",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2019493435",
|
|
"model": "EX-100cm",
|
|
"batchNo": "A5345715",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-05-01",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000216",
|
|
"occurrenceDate": "2025-10-05",
|
|
"registrationDate": "2025-10-13",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015238995",
|
|
"model": "IS-5.0",
|
|
"batchNo": "K4023951",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-10-17",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000217",
|
|
"occurrenceDate": "2024-07-26",
|
|
"registrationDate": "2024-08-04",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2017165659",
|
|
"model": "4251625",
|
|
"batchNo": "G1194068",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-08-09",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000218",
|
|
"occurrenceDate": "2026-02-14",
|
|
"registrationDate": "2026-02-19",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2018152053",
|
|
"model": "PF-7.0",
|
|
"batchNo": "K8845135",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2026-02-26",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000219",
|
|
"occurrenceDate": "2024-12-11",
|
|
"registrationDate": "2024-12-21",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016590098",
|
|
"model": "4053000",
|
|
"batchNo": "C6510978",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-12-27",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000220",
|
|
"occurrenceDate": "2024-10-24",
|
|
"registrationDate": "2024-10-27",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016969454",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "F6715407",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-11-01",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000221",
|
|
"occurrenceDate": "2024-08-27",
|
|
"registrationDate": "2024-09-05",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2019192354",
|
|
"model": "EX-100cm",
|
|
"batchNo": "J1329863",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-09-10",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000222",
|
|
"occurrenceDate": "2025-12-27",
|
|
"registrationDate": "2026-01-06",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2017821828",
|
|
"model": "PF-5.0",
|
|
"batchNo": "G9705247",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2026-01-12",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000223",
|
|
"occurrenceDate": "2025-12-18",
|
|
"registrationDate": "2025-12-26",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进208863610",
|
|
"model": "ACID-8L",
|
|
"batchNo": "H1660644",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-12-30",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000224",
|
|
"occurrenceDate": "2025-03-31",
|
|
"registrationDate": "2025-04-01",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2016109593",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "B6964004",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2025-04-04",
|
|
"province": "天津市",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000225",
|
|
"occurrenceDate": "2025-04-20",
|
|
"registrationDate": "2025-04-28",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018590688",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C9987830",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-05-02",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000226",
|
|
"occurrenceDate": "2024-08-04",
|
|
"registrationDate": "2024-08-09",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进206890487",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "D1556902",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-08-16",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000227",
|
|
"occurrenceDate": "2024-05-17",
|
|
"registrationDate": "2024-05-24",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准205340897",
|
|
"model": "EX-100cm",
|
|
"batchNo": "J2287375",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-05-27",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000228",
|
|
"occurrenceDate": "2024-05-21",
|
|
"registrationDate": "2024-05-24",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209552054",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "D4108772",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-05-29",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000229",
|
|
"occurrenceDate": "2025-10-14",
|
|
"registrationDate": "2025-10-18",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205114425",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "F6183612",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-10-24",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000230",
|
|
"occurrenceDate": "2024-01-15",
|
|
"registrationDate": "2024-01-26",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进206753554",
|
|
"model": "EX-50cm",
|
|
"batchNo": "C2169214",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-02-02",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000231",
|
|
"occurrenceDate": "2026-02-11",
|
|
"registrationDate": "2026-02-21",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018784346",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H5549319",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2026-02-27",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000232",
|
|
"occurrenceDate": "2024-03-30",
|
|
"registrationDate": "2024-04-01",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207320963",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "D7166800",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2024-04-05",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000233",
|
|
"occurrenceDate": "2024-03-31",
|
|
"registrationDate": "2024-04-07",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206582837",
|
|
"model": "PF-7.0",
|
|
"batchNo": "B6138034",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-04-10",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000234",
|
|
"occurrenceDate": "2025-01-26",
|
|
"registrationDate": "2025-01-30",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2015880802",
|
|
"model": "BIC-35",
|
|
"batchNo": "F4390863",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-02-05",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000235",
|
|
"occurrenceDate": "2026-01-19",
|
|
"registrationDate": "2026-01-30",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016187757",
|
|
"model": "4053000",
|
|
"batchNo": "F9326251",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2026-02-06",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000236",
|
|
"occurrenceDate": "2024-05-11",
|
|
"registrationDate": "2024-05-22",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进206954683",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F9326251",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-05-29",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000237",
|
|
"occurrenceDate": "2025-10-31",
|
|
"registrationDate": "2025-11-05",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2016503027",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "G7775084",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-11-12",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000238",
|
|
"occurrenceDate": "2024-10-12",
|
|
"registrationDate": "2024-10-17",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2015329182",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "J8001505",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2024-10-24",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000239",
|
|
"occurrenceDate": "2025-06-17",
|
|
"registrationDate": "2025-06-24",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2017428438",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "J4186614",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-06-27",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000240",
|
|
"occurrenceDate": "2026-03-22",
|
|
"registrationDate": "2026-03-25",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2015874114",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K6217427",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2026-03-30",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000241",
|
|
"occurrenceDate": "2024-06-12",
|
|
"registrationDate": "2024-06-14",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2019686679",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "G1663629",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2024-06-18",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000242",
|
|
"occurrenceDate": "2026-03-09",
|
|
"registrationDate": "2026-03-20",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019280459",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "K3671234",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2026-03-27",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000243",
|
|
"occurrenceDate": "2025-01-21",
|
|
"registrationDate": "2025-01-25",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209922167",
|
|
"model": "HD-180",
|
|
"batchNo": "E4950388",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2025-01-31",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000244",
|
|
"occurrenceDate": "2026-03-08",
|
|
"registrationDate": "2026-03-13",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进205155076",
|
|
"model": "BIC-35",
|
|
"batchNo": "D7554574",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2026-03-20",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000245",
|
|
"occurrenceDate": "2025-07-07",
|
|
"registrationDate": "2025-07-16",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进2018990157",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "C4881853",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2025-07-21",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000246",
|
|
"occurrenceDate": "2025-02-04",
|
|
"registrationDate": "2025-02-11",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015427204",
|
|
"model": "PF-7.0",
|
|
"batchNo": "K1412515",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-02-14",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000247",
|
|
"occurrenceDate": "2025-07-27",
|
|
"registrationDate": "2025-08-04",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准205503182",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F3935599",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-08-08",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000248",
|
|
"occurrenceDate": "2024-12-15",
|
|
"registrationDate": "2024-12-26",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2016568779",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "D6894759",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-01-02",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000249",
|
|
"occurrenceDate": "2024-07-04",
|
|
"registrationDate": "2024-07-07",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准209362542",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "K6870670",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-07-12",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000250",
|
|
"occurrenceDate": "2024-11-03",
|
|
"registrationDate": "2024-11-14",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2019749391",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "C2973445",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-11-21",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000251",
|
|
"occurrenceDate": "2024-09-05",
|
|
"registrationDate": "2024-09-08",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2017695078",
|
|
"model": "PF-5.0",
|
|
"batchNo": "A5696739",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-09-13",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000252",
|
|
"occurrenceDate": "2024-07-23",
|
|
"registrationDate": "2024-07-30",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018783310",
|
|
"model": "EX-100cm",
|
|
"batchNo": "C4999804",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-08-02",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000253",
|
|
"occurrenceDate": "2026-03-01",
|
|
"registrationDate": "2026-03-06",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019484784",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "K4047100",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2026-03-13",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000254",
|
|
"occurrenceDate": "2026-01-11",
|
|
"registrationDate": "2026-01-19",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进208432913",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E7581506",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2026-01-23",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000255",
|
|
"occurrenceDate": "2025-12-17",
|
|
"registrationDate": "2025-12-29",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准209160240",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "A7698921",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2026-01-06",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000256",
|
|
"occurrenceDate": "2025-01-31",
|
|
"registrationDate": "2025-02-09",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019471288",
|
|
"model": "4251625",
|
|
"batchNo": "C9138106",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-02-14",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000257",
|
|
"occurrenceDate": "2024-07-14",
|
|
"registrationDate": "2024-07-25",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进205818074",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "H6324441",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-08-01",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000258",
|
|
"occurrenceDate": "2026-01-16",
|
|
"registrationDate": "2026-01-22",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207563229",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "E6449616",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2026-01-30",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000259",
|
|
"occurrenceDate": "2025-05-24",
|
|
"registrationDate": "2025-06-05",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018872803",
|
|
"model": "4251624",
|
|
"batchNo": "A6061102",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-06-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000260",
|
|
"occurrenceDate": "2025-06-21",
|
|
"registrationDate": "2025-07-03",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207889062",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J6920586",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000261",
|
|
"occurrenceDate": "2025-11-21",
|
|
"registrationDate": "2025-11-26",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207966580",
|
|
"model": "4251624",
|
|
"batchNo": "D5654833",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-12-03",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000262",
|
|
"occurrenceDate": "2025-03-16",
|
|
"registrationDate": "2025-03-21",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准206985220",
|
|
"model": "10ml Luer",
|
|
"batchNo": "E5347675",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000263",
|
|
"occurrenceDate": "2024-08-09",
|
|
"registrationDate": "2024-08-15",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2019527002",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "K5098793",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2024-08-23",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000264",
|
|
"occurrenceDate": "2024-01-28",
|
|
"registrationDate": "2024-01-29",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019491127",
|
|
"model": "4251624",
|
|
"batchNo": "D2812677",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-02-01",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000265",
|
|
"occurrenceDate": "2025-02-11",
|
|
"registrationDate": "2025-02-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2019683819",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "D9296544",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2025-02-21",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000266",
|
|
"occurrenceDate": "2024-08-12",
|
|
"registrationDate": "2024-08-23",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准209707542",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "C2616436",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000267",
|
|
"occurrenceDate": "2024-02-12",
|
|
"registrationDate": "2024-02-22",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016250415",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J4093991",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-02-28",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000268",
|
|
"occurrenceDate": "2024-04-01",
|
|
"registrationDate": "2024-04-12",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2015723678",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H4114114",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-04-19",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000269",
|
|
"occurrenceDate": "2025-01-04",
|
|
"registrationDate": "2025-01-16",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209158745",
|
|
"model": "4053000",
|
|
"batchNo": "B1615644",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-01-24",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000270",
|
|
"occurrenceDate": "2024-07-15",
|
|
"registrationDate": "2024-07-22",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2018526005",
|
|
"model": "4053000",
|
|
"batchNo": "K5730186",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-07-25",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000271",
|
|
"occurrenceDate": "2025-07-24",
|
|
"registrationDate": "2025-07-29",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准209594248",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "K4933517",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-08-05",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000272",
|
|
"occurrenceDate": "2024-12-12",
|
|
"registrationDate": "2024-12-15",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017903589",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D7487254",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-12-20",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000273",
|
|
"occurrenceDate": "2024-08-28",
|
|
"registrationDate": "2024-09-06",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准209177096",
|
|
"model": "4053000",
|
|
"batchNo": "H4215617",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-09-11",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000274",
|
|
"occurrenceDate": "2024-06-21",
|
|
"registrationDate": "2024-06-26",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2016625110",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "C9137595",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-07-03",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000275",
|
|
"occurrenceDate": "2026-03-11",
|
|
"registrationDate": "2026-03-23",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015479693",
|
|
"model": "4053000",
|
|
"batchNo": "A8845249",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2026-03-31",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000276",
|
|
"occurrenceDate": "2025-04-08",
|
|
"registrationDate": "2025-04-14",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018718281",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A6919997",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2025-04-22",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000277",
|
|
"occurrenceDate": "2024-08-17",
|
|
"registrationDate": "2024-08-19",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019187941",
|
|
"model": "4251624",
|
|
"batchNo": "J6961919",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2024-08-23",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000278",
|
|
"occurrenceDate": "2025-12-28",
|
|
"registrationDate": "2026-01-05",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进205641330",
|
|
"model": "4251624",
|
|
"batchNo": "D2297234",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2026-01-09",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000279",
|
|
"occurrenceDate": "2024-08-08",
|
|
"registrationDate": "2024-08-10",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准205435923",
|
|
"model": "IS-5.0",
|
|
"batchNo": "G3849997",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-08-14",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000280",
|
|
"occurrenceDate": "2024-12-03",
|
|
"registrationDate": "2024-12-07",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进205502416",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "A4081163",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2024-12-13",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000281",
|
|
"occurrenceDate": "2025-08-23",
|
|
"registrationDate": "2025-08-25",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2019157005",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "J4274124",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-08-29",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000282",
|
|
"occurrenceDate": "2025-06-05",
|
|
"registrationDate": "2025-06-08",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2019461702",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D6388224",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-06-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000283",
|
|
"occurrenceDate": "2024-06-09",
|
|
"registrationDate": "2024-06-20",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进206785707",
|
|
"model": "HD-180",
|
|
"batchNo": "J1901984",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-06-27",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000284",
|
|
"occurrenceDate": "2024-11-27",
|
|
"registrationDate": "2024-12-06",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018505071",
|
|
"model": "4251624",
|
|
"batchNo": "A1182079",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-12-11",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000285",
|
|
"occurrenceDate": "2024-03-11",
|
|
"registrationDate": "2024-03-15",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015294021",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F4469258",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-03-21",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000286",
|
|
"occurrenceDate": "2024-07-01",
|
|
"registrationDate": "2024-07-11",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2019663362",
|
|
"model": "ACID-8L",
|
|
"batchNo": "C6202671",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-07-17",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000287",
|
|
"occurrenceDate": "2025-10-16",
|
|
"registrationDate": "2025-10-19",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2015232838",
|
|
"model": "EX-50cm",
|
|
"batchNo": "C4867687",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-10-24",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000288",
|
|
"occurrenceDate": "2025-09-13",
|
|
"registrationDate": "2025-09-23",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进209141079",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "C4828662",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-09-29",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000289",
|
|
"occurrenceDate": "2026-03-19",
|
|
"registrationDate": "2026-03-20",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206282429",
|
|
"model": "4053000",
|
|
"batchNo": "J5949178",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2026-03-23",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000290",
|
|
"occurrenceDate": "2024-02-02",
|
|
"registrationDate": "2024-02-04",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209234870",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "H5043678",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-02-08",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000291",
|
|
"occurrenceDate": "2024-05-02",
|
|
"registrationDate": "2024-05-05",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进205294729",
|
|
"model": "EX-50cm",
|
|
"batchNo": "G9970247",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-05-10",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000292",
|
|
"occurrenceDate": "2025-02-20",
|
|
"registrationDate": "2025-02-23",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209997995",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "F4216179",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-02-28",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000293",
|
|
"occurrenceDate": "2024-04-22",
|
|
"registrationDate": "2024-05-03",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进205189116",
|
|
"model": "BIC-35",
|
|
"batchNo": "D3213041",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-05-10",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000294",
|
|
"occurrenceDate": "2025-04-14",
|
|
"registrationDate": "2025-04-25",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准208721680",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "D6854413",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-05-02",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000295",
|
|
"occurrenceDate": "2024-10-06",
|
|
"registrationDate": "2024-10-14",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2018370344",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E7273216",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-10-18",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000296",
|
|
"occurrenceDate": "2024-04-22",
|
|
"registrationDate": "2024-04-23",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准207163427",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "C6978245",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2024-04-26",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000297",
|
|
"occurrenceDate": "2024-08-08",
|
|
"registrationDate": "2024-08-10",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进206644449",
|
|
"model": "20ml Luer",
|
|
"batchNo": "G7886506",
|
|
"injuryExpression": "给药剂量偏差相关不适",
|
|
"deviceFailure": "刻度印刷模糊",
|
|
"reviewDate": "2024-08-14",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000298",
|
|
"occurrenceDate": "2024-05-16",
|
|
"registrationDate": "2024-05-17",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进205590186",
|
|
"model": "BIC-35",
|
|
"batchNo": "D9723363",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-05-20",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000299",
|
|
"occurrenceDate": "2024-09-16",
|
|
"registrationDate": "2024-09-25",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2017355905",
|
|
"model": "10ml Luer",
|
|
"batchNo": "F7883514",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2024-09-30",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000300",
|
|
"occurrenceDate": "2025-10-10",
|
|
"registrationDate": "2025-10-12",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207744571",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "H5816767",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-10-16",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000301",
|
|
"occurrenceDate": "2025-12-02",
|
|
"registrationDate": "2025-12-06",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进208382263",
|
|
"model": "EX-100cm",
|
|
"batchNo": "E2137016",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-12-12",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000302",
|
|
"occurrenceDate": "2025-07-15",
|
|
"registrationDate": "2025-07-22",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019833236",
|
|
"model": "HD-180",
|
|
"batchNo": "K2623548",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-07-25",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000303",
|
|
"occurrenceDate": "2024-03-10",
|
|
"registrationDate": "2024-03-20",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208648402",
|
|
"model": "4053000",
|
|
"batchNo": "A3887920",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-03-26",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000304",
|
|
"occurrenceDate": "2026-02-10",
|
|
"registrationDate": "2026-02-17",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016238952",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F1901121",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2026-02-20",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000305",
|
|
"occurrenceDate": "2025-10-05",
|
|
"registrationDate": "2025-10-13",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208721685",
|
|
"model": "IS-5.0",
|
|
"batchNo": "K6560526",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2025-10-17",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000306",
|
|
"occurrenceDate": "2024-06-07",
|
|
"registrationDate": "2024-06-14",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进205915882",
|
|
"model": "ACID-8L",
|
|
"batchNo": "B2310411",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-06-17",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000307",
|
|
"occurrenceDate": "2024-02-05",
|
|
"registrationDate": "2024-02-12",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2015879334",
|
|
"model": "ACID-8L",
|
|
"batchNo": "D2062767",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-02-15",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000308",
|
|
"occurrenceDate": "2024-11-14",
|
|
"registrationDate": "2024-11-20",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进208356609",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "E7131750",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-11-28",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000309",
|
|
"occurrenceDate": "2023-12-08",
|
|
"registrationDate": "2023-12-14",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019792358",
|
|
"model": "4053000",
|
|
"batchNo": "E2201520",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2023-12-22",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000310",
|
|
"occurrenceDate": "2025-10-09",
|
|
"registrationDate": "2025-10-17",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准205661829",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H1853360",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-10-21",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000311",
|
|
"occurrenceDate": "2025-01-28",
|
|
"registrationDate": "2025-02-04",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进207298227",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "K8265163",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2025-02-07",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000312",
|
|
"occurrenceDate": "2026-02-13",
|
|
"registrationDate": "2026-02-22",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2019933207",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "F1005389",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2026-02-27",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000313",
|
|
"occurrenceDate": "2024-06-14",
|
|
"registrationDate": "2024-06-23",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进205515002",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "E2825111",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2024-06-28",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000314",
|
|
"occurrenceDate": "2026-03-07",
|
|
"registrationDate": "2026-03-19",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019521726",
|
|
"model": "HD-180",
|
|
"batchNo": "K9803055",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2026-03-27",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000315",
|
|
"occurrenceDate": "2024-11-01",
|
|
"registrationDate": "2024-11-08",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2016945979",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "B5646405",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-11-11",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000316",
|
|
"occurrenceDate": "2025-06-10",
|
|
"registrationDate": "2025-06-13",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准205585933",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "J3432729",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-06-18",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000317",
|
|
"occurrenceDate": "2025-04-10",
|
|
"registrationDate": "2025-04-13",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207239728",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "D1568329",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-04-18",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000318",
|
|
"occurrenceDate": "2024-04-05",
|
|
"registrationDate": "2024-04-07",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准205979135",
|
|
"model": "IS-5.0",
|
|
"batchNo": "F5825807",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-04-11",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000319",
|
|
"occurrenceDate": "2024-07-17",
|
|
"registrationDate": "2024-07-23",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2019596272",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "E4837770",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2024-07-31",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000320",
|
|
"occurrenceDate": "2025-03-11",
|
|
"registrationDate": "2025-03-14",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2017209765",
|
|
"model": "BIC-35",
|
|
"batchNo": "K2434563",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2025-03-19",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000321",
|
|
"occurrenceDate": "2024-07-21",
|
|
"registrationDate": "2024-07-26",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2016973869",
|
|
"model": "EX-50cm",
|
|
"batchNo": "G4515946",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-08-02",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000322",
|
|
"occurrenceDate": "2025-11-17",
|
|
"registrationDate": "2025-11-27",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2019140727",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "J5931214",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2025-12-03",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000323",
|
|
"occurrenceDate": "2026-03-27",
|
|
"registrationDate": "2026-04-05",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018662949",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H1786092",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2026-04-10",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000324",
|
|
"occurrenceDate": "2025-06-21",
|
|
"registrationDate": "2025-06-28",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2018942524",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "H6502222",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2025-07-01",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000325",
|
|
"occurrenceDate": "2024-03-14",
|
|
"registrationDate": "2024-03-25",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2019123866",
|
|
"model": "EX-100cm",
|
|
"batchNo": "F7023744",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-04-01",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000326",
|
|
"occurrenceDate": "2024-09-14",
|
|
"registrationDate": "2024-09-18",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2018826684",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "F3053660",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2024-09-24",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000327",
|
|
"occurrenceDate": "2026-01-28",
|
|
"registrationDate": "2026-02-05",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017271591",
|
|
"model": "IS-5.0",
|
|
"batchNo": "J4350448",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2026-02-09",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000328",
|
|
"occurrenceDate": "2024-04-28",
|
|
"registrationDate": "2024-05-03",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准209506586",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "K1731328",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2024-05-10",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000329",
|
|
"occurrenceDate": "2025-12-13",
|
|
"registrationDate": "2025-12-15",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206192146",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "H5376411",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2025-12-19",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000330",
|
|
"occurrenceDate": "2025-07-18",
|
|
"registrationDate": "2025-07-22",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208652801",
|
|
"model": "IS-5.0",
|
|
"batchNo": "B3168784",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-07-28",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000331",
|
|
"occurrenceDate": "2025-05-27",
|
|
"registrationDate": "2025-05-29",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2019698010",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "D8373974",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-06-02",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000332",
|
|
"occurrenceDate": "2024-11-19",
|
|
"registrationDate": "2024-11-28",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017246595",
|
|
"model": "IS-5.0",
|
|
"batchNo": "B5066917",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-12-03",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000333",
|
|
"occurrenceDate": "2024-10-29",
|
|
"registrationDate": "2024-11-05",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207298802",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D9316073",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-11-08",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000334",
|
|
"occurrenceDate": "2024-02-18",
|
|
"registrationDate": "2024-02-29",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208628119",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "J2383481",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-03-07",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000335",
|
|
"occurrenceDate": "2024-04-20",
|
|
"registrationDate": "2024-05-02",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准206728157",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H6225019",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-05-10",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000336",
|
|
"occurrenceDate": "2024-10-05",
|
|
"registrationDate": "2024-10-16",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207600649",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D7445443",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-10-23",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000337",
|
|
"occurrenceDate": "2024-08-03",
|
|
"registrationDate": "2024-08-04",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205559508",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H7434016",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2024-08-07",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000338",
|
|
"occurrenceDate": "2024-02-21",
|
|
"registrationDate": "2024-02-26",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准209978185",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K4314670",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-03-04",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000339",
|
|
"occurrenceDate": "2025-11-08",
|
|
"registrationDate": "2025-11-10",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2018857776",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "K4022303",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-11-14",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000340",
|
|
"occurrenceDate": "2026-02-28",
|
|
"registrationDate": "2026-03-01",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2016320822",
|
|
"model": "ACID-8L",
|
|
"batchNo": "E3029463",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-03-04",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000341",
|
|
"occurrenceDate": "2025-11-12",
|
|
"registrationDate": "2025-11-24",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进205230421",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F7091582",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-12-02",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000342",
|
|
"occurrenceDate": "2025-03-04",
|
|
"registrationDate": "2025-03-07",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207345547",
|
|
"model": "4053000",
|
|
"batchNo": "E3465754",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-03-12",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000343",
|
|
"occurrenceDate": "2025-10-27",
|
|
"registrationDate": "2025-11-03",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016256068",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F6407282",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-11-06",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000344",
|
|
"occurrenceDate": "2025-03-28",
|
|
"registrationDate": "2025-04-01",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进209414095",
|
|
"model": "10ml Luer",
|
|
"batchNo": "D5830958",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2025-04-07",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000345",
|
|
"occurrenceDate": "2025-02-20",
|
|
"registrationDate": "2025-03-04",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准207340003",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C3005576",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-03-12",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000346",
|
|
"occurrenceDate": "2025-02-08",
|
|
"registrationDate": "2025-02-18",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进2016286572",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "D9178998",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2025-02-24",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000347",
|
|
"occurrenceDate": "2025-04-12",
|
|
"registrationDate": "2025-04-17",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019266256",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J8476511",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-04-24",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000348",
|
|
"occurrenceDate": "2024-03-16",
|
|
"registrationDate": "2024-03-24",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2017945758",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "J8737421",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-03-28",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000349",
|
|
"occurrenceDate": "2024-07-08",
|
|
"registrationDate": "2024-07-09",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018554984",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "D3231111",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-07-12",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000350",
|
|
"occurrenceDate": "2025-10-28",
|
|
"registrationDate": "2025-11-07",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进207749784",
|
|
"model": "ACID-8L",
|
|
"batchNo": "A2836510",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-11-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000351",
|
|
"occurrenceDate": "2026-02-01",
|
|
"registrationDate": "2026-02-12",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208321549",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "H1675279",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2026-02-19",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000352",
|
|
"occurrenceDate": "2025-12-01",
|
|
"registrationDate": "2025-12-08",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2019742774",
|
|
"model": "HD-180",
|
|
"batchNo": "B1760244",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2025-12-11",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000353",
|
|
"occurrenceDate": "2024-05-31",
|
|
"registrationDate": "2024-06-09",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2018157792",
|
|
"model": "IS-5.0",
|
|
"batchNo": "K6194647",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-06-14",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000354",
|
|
"occurrenceDate": "2025-06-08",
|
|
"registrationDate": "2025-06-16",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207178012",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "K9179667",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-06-20",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000355",
|
|
"occurrenceDate": "2025-04-07",
|
|
"registrationDate": "2025-04-10",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2017348391",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J1978964",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-04-15",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000356",
|
|
"occurrenceDate": "2024-02-10",
|
|
"registrationDate": "2024-02-11",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018463262",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "H3546800",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-02-14",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000357",
|
|
"occurrenceDate": "2024-12-22",
|
|
"registrationDate": "2024-12-26",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进208487648",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "D1888370",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-01-01",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000358",
|
|
"occurrenceDate": "2024-06-10",
|
|
"registrationDate": "2024-06-16",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207749356",
|
|
"model": "HD-180",
|
|
"batchNo": "J4232979",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-06-24",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000359",
|
|
"occurrenceDate": "2025-06-09",
|
|
"registrationDate": "2025-06-18",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2015807430",
|
|
"model": "20ml Luer",
|
|
"batchNo": "B8430028",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2025-06-23",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000360",
|
|
"occurrenceDate": "2026-01-18",
|
|
"registrationDate": "2026-01-21",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准205167674",
|
|
"model": "IS-5.0",
|
|
"batchNo": "J3252176",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2026-01-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000361",
|
|
"occurrenceDate": "2025-06-26",
|
|
"registrationDate": "2025-07-05",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准205347698",
|
|
"model": "20ml Luer",
|
|
"batchNo": "E4216683",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2025-07-10",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000362",
|
|
"occurrenceDate": "2026-01-05",
|
|
"registrationDate": "2026-01-16",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206104110",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J2193741",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2026-01-23",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000363",
|
|
"occurrenceDate": "2025-12-22",
|
|
"registrationDate": "2025-12-29",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准205111701",
|
|
"model": "10ml Luer",
|
|
"batchNo": "K4555861",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2026-01-01",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000364",
|
|
"occurrenceDate": "2024-01-09",
|
|
"registrationDate": "2024-01-19",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207187750",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "D5208392",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-01-25",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000365",
|
|
"occurrenceDate": "2024-10-30",
|
|
"registrationDate": "2024-11-08",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205776517",
|
|
"model": "IS-5.0",
|
|
"batchNo": "A7406954",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-11-13",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000366",
|
|
"occurrenceDate": "2024-12-22",
|
|
"registrationDate": "2024-12-27",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进208214765",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "B2208850",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-01-03",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000367",
|
|
"occurrenceDate": "2026-03-22",
|
|
"registrationDate": "2026-03-26",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209492931",
|
|
"model": "4251624",
|
|
"batchNo": "J2273419",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2026-04-01",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000368",
|
|
"occurrenceDate": "2024-05-06",
|
|
"registrationDate": "2024-05-17",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2017807793",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A3689278",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000369",
|
|
"occurrenceDate": "2025-02-05",
|
|
"registrationDate": "2025-02-14",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进205376975",
|
|
"model": "10ml Luer",
|
|
"batchNo": "F7623947",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2025-02-19",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000370",
|
|
"occurrenceDate": "2024-11-23",
|
|
"registrationDate": "2024-11-25",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2017415633",
|
|
"model": "PF-5.0",
|
|
"batchNo": "A2379486",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-11-29",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000371",
|
|
"occurrenceDate": "2025-04-07",
|
|
"registrationDate": "2025-04-08",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准207161858",
|
|
"model": "4251624",
|
|
"batchNo": "G7054200",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-04-11",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000372",
|
|
"occurrenceDate": "2025-10-02",
|
|
"registrationDate": "2025-10-13",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2017413898",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "C5713566",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-10-20",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000373",
|
|
"occurrenceDate": "2024-12-31",
|
|
"registrationDate": "2025-01-07",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2019891190",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "J9308217",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2025-01-10",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000374",
|
|
"occurrenceDate": "2024-01-08",
|
|
"registrationDate": "2024-01-19",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进206984825",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "C8776226",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000375",
|
|
"occurrenceDate": "2024-03-03",
|
|
"registrationDate": "2024-03-11",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2018704850",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "F7025813",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2024-03-15",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000376",
|
|
"occurrenceDate": "2025-10-09",
|
|
"registrationDate": "2025-10-15",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准207756238",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "G5687967",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-10-23",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000377",
|
|
"occurrenceDate": "2023-12-14",
|
|
"registrationDate": "2023-12-26",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准207612300",
|
|
"model": "4251625",
|
|
"batchNo": "E6662446",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-01-03",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000378",
|
|
"occurrenceDate": "2024-03-23",
|
|
"registrationDate": "2024-04-04",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进207397168",
|
|
"model": "ACID-8L",
|
|
"batchNo": "E8554750",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-04-12",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000379",
|
|
"occurrenceDate": "2024-05-11",
|
|
"registrationDate": "2024-05-13",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2019215123",
|
|
"model": "EX-100cm",
|
|
"batchNo": "D3917209",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-05-17",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000380",
|
|
"occurrenceDate": "2024-02-16",
|
|
"registrationDate": "2024-02-28",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2017135295",
|
|
"model": "EX-50cm",
|
|
"batchNo": "K6178622",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-03-07",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000381",
|
|
"occurrenceDate": "2024-04-24",
|
|
"registrationDate": "2024-04-30",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019501820",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "G1795416",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-05-08",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000382",
|
|
"occurrenceDate": "2026-01-24",
|
|
"registrationDate": "2026-01-26",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019707463",
|
|
"model": "HD-180",
|
|
"batchNo": "E6138020",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2026-01-30",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000383",
|
|
"occurrenceDate": "2024-09-30",
|
|
"registrationDate": "2024-10-06",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准206157444",
|
|
"model": "PF-7.0",
|
|
"batchNo": "F2559253",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-10-14",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000384",
|
|
"occurrenceDate": "2024-11-15",
|
|
"registrationDate": "2024-11-24",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进208319949",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "D6715829",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-11-29",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000385",
|
|
"occurrenceDate": "2025-09-04",
|
|
"registrationDate": "2025-09-05",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208428721",
|
|
"model": "HD-180",
|
|
"batchNo": "F2654655",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-09-08",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000386",
|
|
"occurrenceDate": "2025-02-11",
|
|
"registrationDate": "2025-02-20",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2018891402",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "G5289532",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2025-02-25",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000387",
|
|
"occurrenceDate": "2024-11-05",
|
|
"registrationDate": "2024-11-15",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2016116189",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F7097920",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2024-11-21",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000388",
|
|
"occurrenceDate": "2025-05-14",
|
|
"registrationDate": "2025-05-16",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206424751",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E1395234",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-05-20",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000389",
|
|
"occurrenceDate": "2025-03-19",
|
|
"registrationDate": "2025-03-22",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2018778149",
|
|
"model": "BIC-35",
|
|
"batchNo": "A5210299",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-03-27",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000390",
|
|
"occurrenceDate": "2023-12-03",
|
|
"registrationDate": "2023-12-08",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206491459",
|
|
"model": "PF-7.0",
|
|
"batchNo": "A7995637",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2023-12-15",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000391",
|
|
"occurrenceDate": "2025-06-28",
|
|
"registrationDate": "2025-07-09",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准208908883",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E3839606",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-07-16",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000392",
|
|
"occurrenceDate": "2025-10-28",
|
|
"registrationDate": "2025-11-01",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207143567",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E3839606",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2025-11-07",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000393",
|
|
"occurrenceDate": "2023-12-10",
|
|
"registrationDate": "2023-12-14",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207174631",
|
|
"model": "HD-180",
|
|
"batchNo": "B9116160",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2023-12-20",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000394",
|
|
"occurrenceDate": "2026-02-19",
|
|
"registrationDate": "2026-02-22",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018403202",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J1895327",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2026-02-27",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000395",
|
|
"occurrenceDate": "2024-01-31",
|
|
"registrationDate": "2024-02-02",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207501645",
|
|
"model": "4251625",
|
|
"batchNo": "K2445277",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-02-06",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000396",
|
|
"occurrenceDate": "2025-10-26",
|
|
"registrationDate": "2025-10-31",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208900253",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "G7088844",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-11-07",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000397",
|
|
"occurrenceDate": "2026-02-21",
|
|
"registrationDate": "2026-03-01",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进206990709",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "C7295966",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2026-03-05",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000398",
|
|
"occurrenceDate": "2024-12-01",
|
|
"registrationDate": "2024-12-08",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206213425",
|
|
"model": "EX-50cm",
|
|
"batchNo": "B8027560",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-12-11",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000399",
|
|
"occurrenceDate": "2025-04-27",
|
|
"registrationDate": "2025-05-07",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2017362856",
|
|
"model": "EX-50cm",
|
|
"batchNo": "B9370073",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-05-13",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000400",
|
|
"occurrenceDate": "2024-12-14",
|
|
"registrationDate": "2024-12-25",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016949375",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F2404684",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2025-01-01",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000401",
|
|
"occurrenceDate": "2025-07-01",
|
|
"registrationDate": "2025-07-08",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015526962",
|
|
"model": "PF-7.0",
|
|
"batchNo": "H5346279",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000402",
|
|
"occurrenceDate": "2026-03-22",
|
|
"registrationDate": "2026-04-01",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206821917",
|
|
"model": "PF-7.0",
|
|
"batchNo": "B7190727",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2026-04-07",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000403",
|
|
"occurrenceDate": "2024-06-29",
|
|
"registrationDate": "2024-07-06",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2019475281",
|
|
"model": "10ml Luer",
|
|
"batchNo": "E9262404",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2024-07-09",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000404",
|
|
"occurrenceDate": "2026-02-28",
|
|
"registrationDate": "2026-03-02",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进2019711969",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "K3278035",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2026-03-06",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000405",
|
|
"occurrenceDate": "2024-05-05",
|
|
"registrationDate": "2024-05-10",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2016761706",
|
|
"model": "BIC-35",
|
|
"batchNo": "D6999827",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-05-17",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000406",
|
|
"occurrenceDate": "2024-09-14",
|
|
"registrationDate": "2024-09-22",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2017918022",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "K6232788",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-09-26",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000407",
|
|
"occurrenceDate": "2023-12-20",
|
|
"registrationDate": "2023-12-30",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进208247718",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D2254666",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2024-01-05",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000408",
|
|
"occurrenceDate": "2025-09-15",
|
|
"registrationDate": "2025-09-21",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进205394764",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "C5049683",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2025-09-29",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000409",
|
|
"occurrenceDate": "2024-02-25",
|
|
"registrationDate": "2024-02-28",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进207881013",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "E1274849",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2024-03-04",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000410",
|
|
"occurrenceDate": "2025-11-18",
|
|
"registrationDate": "2025-11-22",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206439947",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "K6866822",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-11-28",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000411",
|
|
"occurrenceDate": "2025-10-22",
|
|
"registrationDate": "2025-10-30",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2015318981",
|
|
"model": "4053000",
|
|
"batchNo": "G6446227",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-11-03",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000412",
|
|
"occurrenceDate": "2025-08-27",
|
|
"registrationDate": "2025-08-29",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进2018473637",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "F9288108",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-09-02",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000413",
|
|
"occurrenceDate": "2024-07-24",
|
|
"registrationDate": "2024-07-30",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2015791055",
|
|
"model": "BIC-35",
|
|
"batchNo": "E2317382",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-08-07",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000414",
|
|
"occurrenceDate": "2024-10-05",
|
|
"registrationDate": "2024-10-12",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2017563777",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E9290924",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-10-15",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000415",
|
|
"occurrenceDate": "2025-01-17",
|
|
"registrationDate": "2025-01-22",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2019886445",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C3002496",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-01-29",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000416",
|
|
"occurrenceDate": "2024-04-26",
|
|
"registrationDate": "2024-04-27",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2016914599",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "H8959213",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2024-04-30",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000417",
|
|
"occurrenceDate": "2024-06-07",
|
|
"registrationDate": "2024-06-11",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准209831906",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "F2841433",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-06-17",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000418",
|
|
"occurrenceDate": "2025-05-20",
|
|
"registrationDate": "2025-05-30",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准206346302",
|
|
"model": "4053000",
|
|
"batchNo": "A3015561",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-06-05",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000419",
|
|
"occurrenceDate": "2024-02-16",
|
|
"registrationDate": "2024-02-22",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进206636003",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "J6808899",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2024-03-01",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000420",
|
|
"occurrenceDate": "2023-12-26",
|
|
"registrationDate": "2024-01-02",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2016819401",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "G5813447",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2024-01-05",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000421",
|
|
"occurrenceDate": "2024-03-19",
|
|
"registrationDate": "2024-03-23",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进206690040",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "H9193204",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-03-29",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000422",
|
|
"occurrenceDate": "2024-07-01",
|
|
"registrationDate": "2024-07-07",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207480580",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A2286925",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-07-15",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000423",
|
|
"occurrenceDate": "2024-08-17",
|
|
"registrationDate": "2024-08-29",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016830031",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C1222714",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-09-06",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000424",
|
|
"occurrenceDate": "2024-10-24",
|
|
"registrationDate": "2024-10-30",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进205528924",
|
|
"model": "4251625",
|
|
"batchNo": "H1844119",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-11-07",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000425",
|
|
"occurrenceDate": "2023-12-11",
|
|
"registrationDate": "2023-12-21",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016230707",
|
|
"model": "4053000",
|
|
"batchNo": "B9119197",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2023-12-27",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000426",
|
|
"occurrenceDate": "2025-04-03",
|
|
"registrationDate": "2025-04-14",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2015188165",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "B6008169",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2025-04-21",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000427",
|
|
"occurrenceDate": "2025-08-22",
|
|
"registrationDate": "2025-08-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2017458456",
|
|
"model": "PF-5.0",
|
|
"batchNo": "K4053550",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-08-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000428",
|
|
"occurrenceDate": "2025-02-15",
|
|
"registrationDate": "2025-02-26",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准206344406",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "C9323987",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-03-05",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000429",
|
|
"occurrenceDate": "2026-01-02",
|
|
"registrationDate": "2026-01-03",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2018429088",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "D8467716",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2026-01-06",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000430",
|
|
"occurrenceDate": "2024-05-20",
|
|
"registrationDate": "2024-05-21",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2016315509",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A7989382",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000431",
|
|
"occurrenceDate": "2024-11-14",
|
|
"registrationDate": "2024-11-20",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017343947",
|
|
"model": "IS-7.0",
|
|
"batchNo": "C5416224",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-11-28",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000432",
|
|
"occurrenceDate": "2026-03-19",
|
|
"registrationDate": "2026-03-21",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准205448032",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "J4890853",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2026-03-25",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000433",
|
|
"occurrenceDate": "2024-10-21",
|
|
"registrationDate": "2024-10-27",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205420206",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E3064501",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-11-04",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000434",
|
|
"occurrenceDate": "2024-05-12",
|
|
"registrationDate": "2024-05-17",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2015771298",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "F2713130",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000435",
|
|
"occurrenceDate": "2024-04-05",
|
|
"registrationDate": "2024-04-11",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2015855777",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "G4711028",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-04-19",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000436",
|
|
"occurrenceDate": "2025-05-03",
|
|
"registrationDate": "2025-05-10",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018937155",
|
|
"model": "EX-50cm",
|
|
"batchNo": "C4400233",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-05-13",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000437",
|
|
"occurrenceDate": "2025-08-10",
|
|
"registrationDate": "2025-08-15",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206580947",
|
|
"model": "4251625",
|
|
"batchNo": "B3832989",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-08-22",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000438",
|
|
"occurrenceDate": "2025-07-27",
|
|
"registrationDate": "2025-08-04",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进207411944",
|
|
"model": "PF-5.0",
|
|
"batchNo": "H5431862",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-08-08",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000439",
|
|
"occurrenceDate": "2025-09-22",
|
|
"registrationDate": "2025-10-03",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016839637",
|
|
"model": "4053000",
|
|
"batchNo": "A2489688",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-10-10",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000440",
|
|
"occurrenceDate": "2026-01-22",
|
|
"registrationDate": "2026-01-28",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2015394105",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "B2386977",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2026-02-05",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000441",
|
|
"occurrenceDate": "2024-10-30",
|
|
"registrationDate": "2024-11-05",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207675353",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "D7541966",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-11-13",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000442",
|
|
"occurrenceDate": "2025-05-23",
|
|
"registrationDate": "2025-06-01",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准205771815",
|
|
"model": "IS-5.0",
|
|
"batchNo": "J4030807",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-06-06",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000443",
|
|
"occurrenceDate": "2024-03-22",
|
|
"registrationDate": "2024-03-27",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2015470510",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "K4319083",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-04-03",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000444",
|
|
"occurrenceDate": "2024-09-20",
|
|
"registrationDate": "2024-10-01",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2015549600",
|
|
"model": "HD-180",
|
|
"batchNo": "G7551265",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-10-08",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000445",
|
|
"occurrenceDate": "2025-01-17",
|
|
"registrationDate": "2025-01-26",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2017156949",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F8325775",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-01-31",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000446",
|
|
"occurrenceDate": "2025-11-10",
|
|
"registrationDate": "2025-11-21",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016587153",
|
|
"model": "IS-5.0",
|
|
"batchNo": "G1798532",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-11-28",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000447",
|
|
"occurrenceDate": "2025-09-05",
|
|
"registrationDate": "2025-09-14",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进206983514",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "D6934125",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2025-09-19",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000448",
|
|
"occurrenceDate": "2025-01-08",
|
|
"registrationDate": "2025-01-14",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准206384095",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "H1106308",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-01-22",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000449",
|
|
"occurrenceDate": "2024-09-04",
|
|
"registrationDate": "2024-09-14",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019496132",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J6442491",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000450",
|
|
"occurrenceDate": "2025-05-28",
|
|
"registrationDate": "2025-06-07",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准208120461",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "K6999356",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2025-06-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000451",
|
|
"occurrenceDate": "2026-02-12",
|
|
"registrationDate": "2026-02-15",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进207369020",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "D3415831",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2026-02-20",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000452",
|
|
"occurrenceDate": "2025-04-12",
|
|
"registrationDate": "2025-04-14",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准208952572",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F2741057",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-04-18",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000453",
|
|
"occurrenceDate": "2024-12-02",
|
|
"registrationDate": "2024-12-11",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2015501115",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "D3701560",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-12-16",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000454",
|
|
"occurrenceDate": "2024-06-24",
|
|
"registrationDate": "2024-06-25",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208461307",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "A2707948",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-06-28",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000455",
|
|
"occurrenceDate": "2024-11-24",
|
|
"registrationDate": "2024-11-25",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进208786152",
|
|
"model": "10ml Luer",
|
|
"batchNo": "C4531999",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2024-11-28",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000456",
|
|
"occurrenceDate": "2024-01-20",
|
|
"registrationDate": "2024-01-27",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016889990",
|
|
"model": "IS-7.0",
|
|
"batchNo": "B4033112",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-01-30",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000457",
|
|
"occurrenceDate": "2024-07-20",
|
|
"registrationDate": "2024-07-24",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209406051",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "G1503277",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-07-30",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000458",
|
|
"occurrenceDate": "2025-06-19",
|
|
"registrationDate": "2025-06-30",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209387297",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "D6258431",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-07-07",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000459",
|
|
"occurrenceDate": "2025-04-03",
|
|
"registrationDate": "2025-04-06",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进205492000",
|
|
"model": "PF-5.0",
|
|
"batchNo": "J8077938",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-04-11",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000460",
|
|
"occurrenceDate": "2025-12-22",
|
|
"registrationDate": "2025-12-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2016565439",
|
|
"model": "PF-5.0",
|
|
"batchNo": "H6094457",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-12-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000461",
|
|
"occurrenceDate": "2026-03-17",
|
|
"registrationDate": "2026-03-19",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017864748",
|
|
"model": "4053000",
|
|
"batchNo": "C3578783",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2026-03-23",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000462",
|
|
"occurrenceDate": "2025-10-04",
|
|
"registrationDate": "2025-10-12",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019609513",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "J9288533",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-10-16",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000463",
|
|
"occurrenceDate": "2025-10-26",
|
|
"registrationDate": "2025-11-06",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准206715164",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D4729995",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-11-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000464",
|
|
"occurrenceDate": "2024-09-11",
|
|
"registrationDate": "2024-09-21",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209132045",
|
|
"model": "4251625",
|
|
"batchNo": "E2654319",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-09-27",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000465",
|
|
"occurrenceDate": "2024-10-27",
|
|
"registrationDate": "2024-10-31",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2016802680",
|
|
"model": "EX-100cm",
|
|
"batchNo": "H2841702",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-11-06",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000466",
|
|
"occurrenceDate": "2024-01-30",
|
|
"registrationDate": "2024-02-09",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209792734",
|
|
"model": "4251625",
|
|
"batchNo": "A5245934",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-02-15",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000467",
|
|
"occurrenceDate": "2025-04-12",
|
|
"registrationDate": "2025-04-19",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209591086",
|
|
"model": "4251624",
|
|
"batchNo": "C6023457",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-04-22",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000468",
|
|
"occurrenceDate": "2024-01-26",
|
|
"registrationDate": "2024-02-04",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2018724743",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "D8230415",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2024-02-09",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000469",
|
|
"occurrenceDate": "2024-09-18",
|
|
"registrationDate": "2024-09-20",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016965386",
|
|
"model": "4251625",
|
|
"batchNo": "H6321322",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-09-24",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000470",
|
|
"occurrenceDate": "2025-12-08",
|
|
"registrationDate": "2025-12-17",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2017843748",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "G8271291",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2025-12-22",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000471",
|
|
"occurrenceDate": "2025-11-02",
|
|
"registrationDate": "2025-11-12",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2017597597",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "G7411206",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-11-18",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000472",
|
|
"occurrenceDate": "2024-11-30",
|
|
"registrationDate": "2024-12-05",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207627045",
|
|
"model": "4053000",
|
|
"batchNo": "C3565859",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2024-12-12",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000473",
|
|
"occurrenceDate": "2025-01-23",
|
|
"registrationDate": "2025-01-25",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205883582",
|
|
"model": "4053000",
|
|
"batchNo": "B6146084",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-01-29",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000474",
|
|
"occurrenceDate": "2024-09-21",
|
|
"registrationDate": "2024-10-03",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2015562803",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H2836354",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-10-11",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000475",
|
|
"occurrenceDate": "2024-11-15",
|
|
"registrationDate": "2024-11-19",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207828713",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J1681560",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2024-11-25",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000476",
|
|
"occurrenceDate": "2025-09-09",
|
|
"registrationDate": "2025-09-16",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2016714435",
|
|
"model": "20ml Luer",
|
|
"batchNo": "C7981889",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2025-09-19",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000477",
|
|
"occurrenceDate": "2025-12-17",
|
|
"registrationDate": "2025-12-27",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准209171513",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "J4107198",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2026-01-02",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000478",
|
|
"occurrenceDate": "2026-03-26",
|
|
"registrationDate": "2026-03-29",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2018749274",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E5751588",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2026-04-03",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000479",
|
|
"occurrenceDate": "2025-05-17",
|
|
"registrationDate": "2025-05-24",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209801012",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A3532994",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-05-27",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000480",
|
|
"occurrenceDate": "2025-10-22",
|
|
"registrationDate": "2025-11-01",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016230373",
|
|
"model": "HD-180",
|
|
"batchNo": "K5482330",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2025-11-07",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000481",
|
|
"occurrenceDate": "2024-04-19",
|
|
"registrationDate": "2024-04-28",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准209162942",
|
|
"model": "EX-100cm",
|
|
"batchNo": "B9807740",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-05-03",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000482",
|
|
"occurrenceDate": "2025-07-26",
|
|
"registrationDate": "2025-08-02",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017483881",
|
|
"model": "4053000",
|
|
"batchNo": "F2682738",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-08-05",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000483",
|
|
"occurrenceDate": "2025-02-08",
|
|
"registrationDate": "2025-02-10",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2019160554",
|
|
"model": "20ml Luer",
|
|
"batchNo": "E7808179",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2025-02-14",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000484",
|
|
"occurrenceDate": "2024-09-06",
|
|
"registrationDate": "2024-09-12",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015863152",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E1351265",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000485",
|
|
"occurrenceDate": "2025-04-26",
|
|
"registrationDate": "2025-05-04",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2016919995",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "G1392694",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2025-05-08",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000486",
|
|
"occurrenceDate": "2024-02-13",
|
|
"registrationDate": "2024-02-23",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2017449859",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "E6413319",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-02-29",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000487",
|
|
"occurrenceDate": "2025-04-10",
|
|
"registrationDate": "2025-04-22",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进209662563",
|
|
"model": "BIC-35",
|
|
"batchNo": "D6092980",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-04-30",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000488",
|
|
"occurrenceDate": "2024-05-25",
|
|
"registrationDate": "2024-05-29",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2015313224",
|
|
"model": "ACID-8L",
|
|
"batchNo": "H9638055",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2024-06-04",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000489",
|
|
"occurrenceDate": "2024-02-19",
|
|
"registrationDate": "2024-02-20",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2018953064",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F1832056",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-02-23",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000490",
|
|
"occurrenceDate": "2025-05-27",
|
|
"registrationDate": "2025-06-05",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207335032",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K9963715",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-06-10",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000491",
|
|
"occurrenceDate": "2026-02-18",
|
|
"registrationDate": "2026-02-28",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209693999",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F6256190",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2026-03-06",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000492",
|
|
"occurrenceDate": "2025-05-30",
|
|
"registrationDate": "2025-06-08",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准208702301",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "F5997265",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-06-13",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000493",
|
|
"occurrenceDate": "2025-06-27",
|
|
"registrationDate": "2025-07-05",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准207975573",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "K5600190",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-07-09",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000494",
|
|
"occurrenceDate": "2024-09-14",
|
|
"registrationDate": "2024-09-26",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准206806361",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K6382598",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2024-10-04",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000495",
|
|
"occurrenceDate": "2024-01-08",
|
|
"registrationDate": "2024-01-18",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进209543716",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "G8433726",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2024-01-24",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000496",
|
|
"occurrenceDate": "2025-02-26",
|
|
"registrationDate": "2025-03-04",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进2018233557",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "D2928772",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2025-03-12",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000497",
|
|
"occurrenceDate": "2025-02-02",
|
|
"registrationDate": "2025-02-13",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进208394341",
|
|
"model": "EX-50cm",
|
|
"batchNo": "E8639084",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-02-20",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000498",
|
|
"occurrenceDate": "2024-09-11",
|
|
"registrationDate": "2024-09-20",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准209103060",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D5069429",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-09-25",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000499",
|
|
"occurrenceDate": "2025-04-12",
|
|
"registrationDate": "2025-04-22",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2016785019",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F9524845",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-04-28",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000500",
|
|
"occurrenceDate": "2025-08-08",
|
|
"registrationDate": "2025-08-17",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2015461909",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "A6111561",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-08-22",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000501",
|
|
"occurrenceDate": "2026-03-20",
|
|
"registrationDate": "2026-03-29",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进207926140",
|
|
"model": "PF-5.0",
|
|
"batchNo": "H8420731",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2026-04-03",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000502",
|
|
"occurrenceDate": "2025-03-03",
|
|
"registrationDate": "2025-03-04",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018330415",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J7678898",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-03-07",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000503",
|
|
"occurrenceDate": "2025-04-10",
|
|
"registrationDate": "2025-04-12",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准209684410",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H7169949",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-04-16",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000504",
|
|
"occurrenceDate": "2023-12-05",
|
|
"registrationDate": "2023-12-09",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2016565222",
|
|
"model": "EX-50cm",
|
|
"batchNo": "G3163289",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2023-12-15",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000505",
|
|
"occurrenceDate": "2024-05-09",
|
|
"registrationDate": "2024-05-14",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016213552",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "D7827486",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-05-21",
|
|
"province": "浙江省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000506",
|
|
"occurrenceDate": "2025-12-16",
|
|
"registrationDate": "2025-12-23",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018375215",
|
|
"model": "EX-50cm",
|
|
"batchNo": "B2749758",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-12-26",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000507",
|
|
"occurrenceDate": "2023-12-27",
|
|
"registrationDate": "2024-01-02",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进205840565",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "K6100181",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-01-10",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000508",
|
|
"occurrenceDate": "2024-09-25",
|
|
"registrationDate": "2024-09-28",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018180582",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E7806046",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2024-10-03",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000509",
|
|
"occurrenceDate": "2024-08-25",
|
|
"registrationDate": "2024-09-05",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207455045",
|
|
"model": "IS-5.0",
|
|
"batchNo": "K6967623",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-09-12",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000510",
|
|
"occurrenceDate": "2025-11-17",
|
|
"registrationDate": "2025-11-28",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018956393",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H6152769",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2025-12-05",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000511",
|
|
"occurrenceDate": "2025-04-13",
|
|
"registrationDate": "2025-04-21",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206134866",
|
|
"model": "EX-50cm",
|
|
"batchNo": "E4791248",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-04-25",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000512",
|
|
"occurrenceDate": "2024-05-17",
|
|
"registrationDate": "2024-05-19",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016593548",
|
|
"model": "4251624",
|
|
"batchNo": "B4412586",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-05-23",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000513",
|
|
"occurrenceDate": "2025-10-30",
|
|
"registrationDate": "2025-11-02",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2015442397",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "D6410517",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-11-07",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000514",
|
|
"occurrenceDate": "2024-07-17",
|
|
"registrationDate": "2024-07-22",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准205595191",
|
|
"model": "PF-7.0",
|
|
"batchNo": "G5370203",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-07-29",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000515",
|
|
"occurrenceDate": "2024-11-03",
|
|
"registrationDate": "2024-11-08",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2019650878",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "K1513027",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-11-15",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000516",
|
|
"occurrenceDate": "2025-12-26",
|
|
"registrationDate": "2026-01-06",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019598591",
|
|
"model": "HD-180",
|
|
"batchNo": "H4393159",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2026-01-13",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000517",
|
|
"occurrenceDate": "2024-06-03",
|
|
"registrationDate": "2024-06-14",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205173044",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "C1420840",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-06-21",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000518",
|
|
"occurrenceDate": "2025-04-22",
|
|
"registrationDate": "2025-05-04",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208991289",
|
|
"model": "4251624",
|
|
"batchNo": "D5184085",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-05-12",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000519",
|
|
"occurrenceDate": "2023-12-14",
|
|
"registrationDate": "2023-12-17",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017944250",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E4538518",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2023-12-22",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000520",
|
|
"occurrenceDate": "2024-07-31",
|
|
"registrationDate": "2024-08-10",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进206605515",
|
|
"model": "HD-180",
|
|
"batchNo": "H2842840",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-08-16",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000521",
|
|
"occurrenceDate": "2024-02-14",
|
|
"registrationDate": "2024-02-17",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2018872963",
|
|
"model": "BIC-35",
|
|
"batchNo": "B2778576",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-02-22",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000522",
|
|
"occurrenceDate": "2024-02-17",
|
|
"registrationDate": "2024-02-24",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209360741",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F3542724",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-02-27",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000523",
|
|
"occurrenceDate": "2026-01-29",
|
|
"registrationDate": "2026-02-07",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209307777",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D8531009",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2026-02-12",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000524",
|
|
"occurrenceDate": "2025-07-05",
|
|
"registrationDate": "2025-07-13",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2018726642",
|
|
"model": "IS-7.0",
|
|
"batchNo": "A6148440",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-07-17",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000525",
|
|
"occurrenceDate": "2025-09-07",
|
|
"registrationDate": "2025-09-17",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进209801837",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E7372517",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-09-23",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000526",
|
|
"occurrenceDate": "2025-11-01",
|
|
"registrationDate": "2025-11-03",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2016581725",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "F1708173",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-11-07",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000527",
|
|
"occurrenceDate": "2024-04-01",
|
|
"registrationDate": "2024-04-11",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准208426833",
|
|
"model": "EX-100cm",
|
|
"batchNo": "B8360830",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-04-17",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000528",
|
|
"occurrenceDate": "2025-04-25",
|
|
"registrationDate": "2025-05-01",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207733090",
|
|
"model": "IS-7.0",
|
|
"batchNo": "G2731232",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-05-09",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000529",
|
|
"occurrenceDate": "2026-02-12",
|
|
"registrationDate": "2026-02-18",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208419557",
|
|
"model": "4053000",
|
|
"batchNo": "F2166384",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2026-02-26",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000530",
|
|
"occurrenceDate": "2025-03-24",
|
|
"registrationDate": "2025-03-25",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017551391",
|
|
"model": "IS-7.0",
|
|
"batchNo": "B2912887",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000531",
|
|
"occurrenceDate": "2025-01-15",
|
|
"registrationDate": "2025-01-23",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015757533",
|
|
"model": "4251624",
|
|
"batchNo": "B6032500",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-01-27",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000532",
|
|
"occurrenceDate": "2025-05-12",
|
|
"registrationDate": "2025-05-23",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017704365",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "C5759762",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-05-30",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000533",
|
|
"occurrenceDate": "2025-05-16",
|
|
"registrationDate": "2025-05-28",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2019248549",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "A8860461",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2025-06-05",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000534",
|
|
"occurrenceDate": "2025-10-09",
|
|
"registrationDate": "2025-10-21",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2018619082",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "F7318350",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-10-29",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000535",
|
|
"occurrenceDate": "2024-08-19",
|
|
"registrationDate": "2024-08-20",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017567669",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J9751882",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-08-23",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000536",
|
|
"occurrenceDate": "2024-04-28",
|
|
"registrationDate": "2024-05-06",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015266568",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J1526390",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-05-10",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000537",
|
|
"occurrenceDate": "2024-03-10",
|
|
"registrationDate": "2024-03-11",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2018743982",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "A8123481",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2024-03-14",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000538",
|
|
"occurrenceDate": "2024-12-13",
|
|
"registrationDate": "2024-12-19",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2017417459",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "A7637426",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-12-27",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000539",
|
|
"occurrenceDate": "2024-07-27",
|
|
"registrationDate": "2024-07-29",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2016934939",
|
|
"model": "HD-180",
|
|
"batchNo": "B3896579",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-08-02",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000540",
|
|
"occurrenceDate": "2025-12-22",
|
|
"registrationDate": "2025-12-26",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2018860812",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "C9790646",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2026-01-01",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000541",
|
|
"occurrenceDate": "2024-11-16",
|
|
"registrationDate": "2024-11-23",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208774442",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "A4843662",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-11-26",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000542",
|
|
"occurrenceDate": "2025-01-28",
|
|
"registrationDate": "2025-02-04",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018984169",
|
|
"model": "IS-7.0",
|
|
"batchNo": "E8865651",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-02-07",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000543",
|
|
"occurrenceDate": "2024-10-03",
|
|
"registrationDate": "2024-10-06",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准205891277",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "D6248669",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-10-11",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000544",
|
|
"occurrenceDate": "2025-03-22",
|
|
"registrationDate": "2025-04-02",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208758386",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J8335194",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-04-09",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000545",
|
|
"occurrenceDate": "2026-02-26",
|
|
"registrationDate": "2026-03-04",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206419381",
|
|
"model": "4251624",
|
|
"batchNo": "K5813195",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2026-03-12",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000546",
|
|
"occurrenceDate": "2024-01-20",
|
|
"registrationDate": "2024-01-22",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2015143171",
|
|
"model": "HD-180",
|
|
"batchNo": "K1822786",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000547",
|
|
"occurrenceDate": "2024-03-07",
|
|
"registrationDate": "2024-03-16",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进207818055",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "D9809700",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-03-21",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000548",
|
|
"occurrenceDate": "2024-08-18",
|
|
"registrationDate": "2024-08-26",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2016978013",
|
|
"model": "EX-100cm",
|
|
"batchNo": "A6482029",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000549",
|
|
"occurrenceDate": "2025-04-17",
|
|
"registrationDate": "2025-04-19",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207819996",
|
|
"model": "4251624",
|
|
"batchNo": "F1148387",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-04-23",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000550",
|
|
"occurrenceDate": "2025-01-15",
|
|
"registrationDate": "2025-01-25",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208383522",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "J6697225",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-01-31",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000551",
|
|
"occurrenceDate": "2024-01-18",
|
|
"registrationDate": "2024-01-21",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018472757",
|
|
"model": "EX-50cm",
|
|
"batchNo": "D4794846",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000552",
|
|
"occurrenceDate": "2024-04-25",
|
|
"registrationDate": "2024-04-30",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016726918",
|
|
"model": "HD-180",
|
|
"batchNo": "J3947228",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-05-07",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000553",
|
|
"occurrenceDate": "2024-03-17",
|
|
"registrationDate": "2024-03-22",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准206571535",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "B2658454",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-03-29",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000554",
|
|
"occurrenceDate": "2025-03-10",
|
|
"registrationDate": "2025-03-21",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209750512",
|
|
"model": "4251624",
|
|
"batchNo": "J7093395",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000555",
|
|
"occurrenceDate": "2025-01-05",
|
|
"registrationDate": "2025-01-10",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209867235",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "K4147844",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-01-17",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000556",
|
|
"occurrenceDate": "2025-06-02",
|
|
"registrationDate": "2025-06-03",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018708604",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "D1716089",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-06-06",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000557",
|
|
"occurrenceDate": "2025-02-10",
|
|
"registrationDate": "2025-02-14",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205456485",
|
|
"model": "HD-180",
|
|
"batchNo": "K7802019",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-02-20",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000558",
|
|
"occurrenceDate": "2025-09-06",
|
|
"registrationDate": "2025-09-08",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进208566714",
|
|
"model": "PF-7.0",
|
|
"batchNo": "F5307171",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-09-12",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000559",
|
|
"occurrenceDate": "2025-01-21",
|
|
"registrationDate": "2025-01-25",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2015616131",
|
|
"model": "PF-7.0",
|
|
"batchNo": "K1722818",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-01-31",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000560",
|
|
"occurrenceDate": "2024-02-11",
|
|
"registrationDate": "2024-02-19",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018427836",
|
|
"model": "4251625",
|
|
"batchNo": "E1240033",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-02-23",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000561",
|
|
"occurrenceDate": "2025-03-19",
|
|
"registrationDate": "2025-03-27",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2015110417",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "D6576548",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-03-31",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000562",
|
|
"occurrenceDate": "2025-03-07",
|
|
"registrationDate": "2025-03-16",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2015238124",
|
|
"model": "20ml Luer",
|
|
"batchNo": "F8645006",
|
|
"injuryExpression": "给药剂量偏差相关不适",
|
|
"deviceFailure": "刻度印刷模糊",
|
|
"reviewDate": "2025-03-21",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000563",
|
|
"occurrenceDate": "2024-05-14",
|
|
"registrationDate": "2024-05-18",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2016297769",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "B2871659",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000564",
|
|
"occurrenceDate": "2024-07-22",
|
|
"registrationDate": "2024-07-23",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2019218327",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D8699032",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-07-26",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000565",
|
|
"occurrenceDate": "2024-07-19",
|
|
"registrationDate": "2024-07-23",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207460186",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J2244017",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-07-29",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000566",
|
|
"occurrenceDate": "2025-02-12",
|
|
"registrationDate": "2025-02-18",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2017280998",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "F2794653",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-02-26",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000567",
|
|
"occurrenceDate": "2025-11-24",
|
|
"registrationDate": "2025-11-27",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207155708",
|
|
"model": "IS-5.0",
|
|
"batchNo": "H3250620",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-12-02",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000568",
|
|
"occurrenceDate": "2025-02-05",
|
|
"registrationDate": "2025-02-15",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准205608024",
|
|
"model": "IS-5.0",
|
|
"batchNo": "G1571298",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-02-21",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000569",
|
|
"occurrenceDate": "2025-06-01",
|
|
"registrationDate": "2025-06-05",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209814396",
|
|
"model": "4251624",
|
|
"batchNo": "K4653726",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2025-06-11",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000570",
|
|
"occurrenceDate": "2024-04-02",
|
|
"registrationDate": "2024-04-11",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2019657028",
|
|
"model": "10ml Luer",
|
|
"batchNo": "D5438071",
|
|
"injuryExpression": "给药剂量偏差相关不适",
|
|
"deviceFailure": "刻度印刷模糊",
|
|
"reviewDate": "2024-04-16",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000571",
|
|
"occurrenceDate": "2023-12-20",
|
|
"registrationDate": "2024-01-01",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2017732889",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "D7467877",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-01-09",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000572",
|
|
"occurrenceDate": "2024-04-08",
|
|
"registrationDate": "2024-04-11",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2019943262",
|
|
"model": "20ml Luer",
|
|
"batchNo": "C2624880",
|
|
"injuryExpression": "给药剂量偏差相关不适",
|
|
"deviceFailure": "刻度印刷模糊",
|
|
"reviewDate": "2024-04-16",
|
|
"province": "山东省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000573",
|
|
"occurrenceDate": "2025-11-11",
|
|
"registrationDate": "2025-11-18",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208912521",
|
|
"model": "HD-180",
|
|
"batchNo": "F2828449",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-11-21",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000574",
|
|
"occurrenceDate": "2025-10-12",
|
|
"registrationDate": "2025-10-22",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016166650",
|
|
"model": "4251625",
|
|
"batchNo": "E6848196",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2025-10-28",
|
|
"province": "陕西省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000575",
|
|
"occurrenceDate": "2024-09-25",
|
|
"registrationDate": "2024-09-28",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015602572",
|
|
"model": "PF-7.0",
|
|
"batchNo": "H6029138",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-10-03",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000576",
|
|
"occurrenceDate": "2024-05-16",
|
|
"registrationDate": "2024-05-21",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2016418484",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F6155277",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-05-28",
|
|
"province": "陕西省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000577",
|
|
"occurrenceDate": "2024-11-18",
|
|
"registrationDate": "2024-11-29",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016118271",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J7567147",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-12-06",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000578",
|
|
"occurrenceDate": "2025-12-19",
|
|
"registrationDate": "2025-12-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2015983426",
|
|
"model": "HD-180",
|
|
"batchNo": "K4505812",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-12-29",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000579",
|
|
"occurrenceDate": "2026-03-12",
|
|
"registrationDate": "2026-03-18",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2016842841",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "H6719975",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2026-03-26",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000580",
|
|
"occurrenceDate": "2024-06-22",
|
|
"registrationDate": "2024-07-02",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2017118555",
|
|
"model": "HD-180",
|
|
"batchNo": "C5414680",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-07-08",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000581",
|
|
"occurrenceDate": "2025-07-30",
|
|
"registrationDate": "2025-08-08",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准205335150",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F9198359",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-08-13",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000582",
|
|
"occurrenceDate": "2025-03-17",
|
|
"registrationDate": "2025-03-18",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019419940",
|
|
"model": "IS-5.0",
|
|
"batchNo": "F5735623",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-03-21",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000583",
|
|
"occurrenceDate": "2024-03-04",
|
|
"registrationDate": "2024-03-08",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2019464498",
|
|
"model": "10ml Luer",
|
|
"batchNo": "K7981538",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2024-03-14",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000584",
|
|
"occurrenceDate": "2025-01-27",
|
|
"registrationDate": "2025-01-28",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208374205",
|
|
"model": "HD-180",
|
|
"batchNo": "F2731149",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-01-31",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000585",
|
|
"occurrenceDate": "2025-11-20",
|
|
"registrationDate": "2025-11-23",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019378192",
|
|
"model": "4251625",
|
|
"batchNo": "F5478940",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2025-11-28",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000586",
|
|
"occurrenceDate": "2024-08-22",
|
|
"registrationDate": "2024-08-27",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准208841795",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "D1453392",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2024-09-03",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000587",
|
|
"occurrenceDate": "2026-02-18",
|
|
"registrationDate": "2026-02-23",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准205119137",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "D5047274",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2026-03-02",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000588",
|
|
"occurrenceDate": "2024-09-10",
|
|
"registrationDate": "2024-09-14",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209505528",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "D4926296",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000589",
|
|
"occurrenceDate": "2026-02-20",
|
|
"registrationDate": "2026-02-25",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准209634854",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "A6595034",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2026-03-04",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000590",
|
|
"occurrenceDate": "2025-03-18",
|
|
"registrationDate": "2025-03-22",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018577208",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F3777023",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000591",
|
|
"occurrenceDate": "2025-06-12",
|
|
"registrationDate": "2025-06-20",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2019213997",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "A5702449",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2025-06-24",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000592",
|
|
"occurrenceDate": "2025-11-25",
|
|
"registrationDate": "2025-11-29",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019877555",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "B7614285",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-12-05",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000593",
|
|
"occurrenceDate": "2024-03-29",
|
|
"registrationDate": "2024-03-31",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206227885",
|
|
"model": "EX-50cm",
|
|
"batchNo": "J9091061",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-04-04",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000594",
|
|
"occurrenceDate": "2026-02-04",
|
|
"registrationDate": "2026-02-16",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209505683",
|
|
"model": "4251624",
|
|
"batchNo": "E3838712",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2026-02-24",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000595",
|
|
"occurrenceDate": "2026-01-25",
|
|
"registrationDate": "2026-02-01",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准209637812",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "G6686899",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2026-02-04",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000596",
|
|
"occurrenceDate": "2024-05-20",
|
|
"registrationDate": "2024-05-23",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2015712465",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "G3762562",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2024-05-28",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000597",
|
|
"occurrenceDate": "2025-01-30",
|
|
"registrationDate": "2025-02-07",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进209293703",
|
|
"model": "EX-50cm",
|
|
"batchNo": "D5419625",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-02-11",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000598",
|
|
"occurrenceDate": "2024-12-02",
|
|
"registrationDate": "2024-12-09",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018283710",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "D6280418",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-12-12",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000599",
|
|
"occurrenceDate": "2025-05-09",
|
|
"registrationDate": "2025-05-21",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2018790716",
|
|
"model": "PF-7.0",
|
|
"batchNo": "J6154815",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-05-29",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000600",
|
|
"occurrenceDate": "2026-01-22",
|
|
"registrationDate": "2026-01-24",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准209400402",
|
|
"model": "EX-50cm",
|
|
"batchNo": "K5589157",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2026-01-28",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000601",
|
|
"occurrenceDate": "2024-11-09",
|
|
"registrationDate": "2024-11-11",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2019970861",
|
|
"model": "HD-180",
|
|
"batchNo": "F6146525",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-11-15",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000602",
|
|
"occurrenceDate": "2025-12-22",
|
|
"registrationDate": "2025-12-29",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206620033",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J6446429",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2026-01-01",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000603",
|
|
"occurrenceDate": "2024-05-25",
|
|
"registrationDate": "2024-06-05",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209386612",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "A8180519",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-06-12",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000604",
|
|
"occurrenceDate": "2024-06-07",
|
|
"registrationDate": "2024-06-13",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208181534",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J9607818",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-06-21",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000605",
|
|
"occurrenceDate": "2025-10-30",
|
|
"registrationDate": "2025-11-07",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019371516",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "B2010772",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-11-11",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000606",
|
|
"occurrenceDate": "2025-03-06",
|
|
"registrationDate": "2025-03-08",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准205143105",
|
|
"model": "PF-7.0",
|
|
"batchNo": "H1337588",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-03-12",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000607",
|
|
"occurrenceDate": "2024-08-27",
|
|
"registrationDate": "2024-08-31",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207466029",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "G1368748",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-09-06",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000608",
|
|
"occurrenceDate": "2025-06-06",
|
|
"registrationDate": "2025-06-11",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进208366658",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J2859642",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-06-18",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000609",
|
|
"occurrenceDate": "2026-01-11",
|
|
"registrationDate": "2026-01-21",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2017835955",
|
|
"model": "ACID-8L",
|
|
"batchNo": "A9410407",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2026-01-27",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000610",
|
|
"occurrenceDate": "2025-07-24",
|
|
"registrationDate": "2025-07-29",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207151618",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F2495894",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-08-05",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000611",
|
|
"occurrenceDate": "2025-07-06",
|
|
"registrationDate": "2025-07-14",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2019921569",
|
|
"model": "ACID-8L",
|
|
"batchNo": "G4434033",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2025-07-18",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000612",
|
|
"occurrenceDate": "2025-09-14",
|
|
"registrationDate": "2025-09-19",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准205452260",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "A1063621",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-09-26",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000613",
|
|
"occurrenceDate": "2026-03-12",
|
|
"registrationDate": "2026-03-21",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209914714",
|
|
"model": "IS-7.0",
|
|
"batchNo": "E1427463",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2026-03-26",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000614",
|
|
"occurrenceDate": "2026-02-28",
|
|
"registrationDate": "2026-03-04",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209855824",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "B5378282",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2026-03-10",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000615",
|
|
"occurrenceDate": "2025-06-06",
|
|
"registrationDate": "2025-06-13",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018173450",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "D9923698",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-06-16",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000616",
|
|
"occurrenceDate": "2024-10-21",
|
|
"registrationDate": "2024-11-01",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208786388",
|
|
"model": "IS-5.0",
|
|
"batchNo": "F4483196",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-11-08",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000617",
|
|
"occurrenceDate": "2023-12-23",
|
|
"registrationDate": "2023-12-28",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2018444105",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "K7785824",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-01-04",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000618",
|
|
"occurrenceDate": "2025-06-14",
|
|
"registrationDate": "2025-06-26",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209623806",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J2584122",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-07-04",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000619",
|
|
"occurrenceDate": "2024-05-28",
|
|
"registrationDate": "2024-06-03",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206508638",
|
|
"model": "4251624",
|
|
"batchNo": "J9362277",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-06-11",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000620",
|
|
"occurrenceDate": "2026-03-23",
|
|
"registrationDate": "2026-03-27",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2016275223",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "E8061785",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2026-04-02",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000621",
|
|
"occurrenceDate": "2024-01-23",
|
|
"registrationDate": "2024-02-02",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2017651282",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "J3248142",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-02-08",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000622",
|
|
"occurrenceDate": "2024-02-29",
|
|
"registrationDate": "2024-03-08",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2017744862",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "G6124370",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-03-12",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000623",
|
|
"occurrenceDate": "2026-01-18",
|
|
"registrationDate": "2026-01-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208667577",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A9806549",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2026-01-30",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000624",
|
|
"occurrenceDate": "2024-12-12",
|
|
"registrationDate": "2024-12-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准209306826",
|
|
"model": "IS-7.0",
|
|
"batchNo": "B5745720",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-12-20",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000625",
|
|
"occurrenceDate": "2026-03-19",
|
|
"registrationDate": "2026-03-31",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2018887893",
|
|
"model": "BIC-35",
|
|
"batchNo": "D3775973",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-04-08",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000626",
|
|
"occurrenceDate": "2024-06-01",
|
|
"registrationDate": "2024-06-13",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准206587076",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H9824546",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-06-21",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000627",
|
|
"occurrenceDate": "2024-12-18",
|
|
"registrationDate": "2024-12-28",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019637732",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E8731705",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-01-03",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000628",
|
|
"occurrenceDate": "2025-05-29",
|
|
"registrationDate": "2025-06-10",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206989979",
|
|
"model": "4251625",
|
|
"batchNo": "E8511097",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-06-18",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000629",
|
|
"occurrenceDate": "2024-12-01",
|
|
"registrationDate": "2024-12-04",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准205925812",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "F5573389",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-12-09",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000630",
|
|
"occurrenceDate": "2024-08-20",
|
|
"registrationDate": "2024-08-24",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进2015915478",
|
|
"model": "10ml Luer",
|
|
"batchNo": "A2619881",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000631",
|
|
"occurrenceDate": "2024-12-02",
|
|
"registrationDate": "2024-12-03",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2016142102",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A2685591",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-12-06",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000632",
|
|
"occurrenceDate": "2025-08-26",
|
|
"registrationDate": "2025-09-07",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2016550768",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "J1283620",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-09-15",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000633",
|
|
"occurrenceDate": "2024-06-10",
|
|
"registrationDate": "2024-06-14",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208793811",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "G9368310",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-06-20",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000634",
|
|
"occurrenceDate": "2025-07-28",
|
|
"registrationDate": "2025-07-29",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2017385692",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "G9746386",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-08-01",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000635",
|
|
"occurrenceDate": "2025-12-08",
|
|
"registrationDate": "2025-12-09",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准205450418",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E3506526",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-12-12",
|
|
"province": "湖南省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000636",
|
|
"occurrenceDate": "2025-02-17",
|
|
"registrationDate": "2025-02-20",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016558805",
|
|
"model": "IS-7.0",
|
|
"batchNo": "D4852171",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-02-25",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000637",
|
|
"occurrenceDate": "2024-01-02",
|
|
"registrationDate": "2024-01-08",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019260772",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "H1805457",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-01-16",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000638",
|
|
"occurrenceDate": "2025-04-25",
|
|
"registrationDate": "2025-05-01",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2015241177",
|
|
"model": "4053000",
|
|
"batchNo": "E5382495",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-05-09",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000639",
|
|
"occurrenceDate": "2025-12-20",
|
|
"registrationDate": "2025-12-22",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进207676192",
|
|
"model": "PF-5.0",
|
|
"batchNo": "G6212525",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-12-26",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000640",
|
|
"occurrenceDate": "2025-12-15",
|
|
"registrationDate": "2025-12-18",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2017623623",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A1192513",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-12-23",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000641",
|
|
"occurrenceDate": "2025-03-11",
|
|
"registrationDate": "2025-03-18",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205581106",
|
|
"model": "4053000",
|
|
"batchNo": "G9026383",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-03-21",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000642",
|
|
"occurrenceDate": "2024-01-25",
|
|
"registrationDate": "2024-01-26",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209363757",
|
|
"model": "4053000",
|
|
"batchNo": "B2658562",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-01-29",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000643",
|
|
"occurrenceDate": "2024-10-14",
|
|
"registrationDate": "2024-10-21",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209716093",
|
|
"model": "HD-180",
|
|
"batchNo": "F2212118",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-10-24",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000644",
|
|
"occurrenceDate": "2024-07-23",
|
|
"registrationDate": "2024-08-01",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进206506599",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "E7811165",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2024-08-06",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000645",
|
|
"occurrenceDate": "2025-12-13",
|
|
"registrationDate": "2025-12-23",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206464430",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "G8155302",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2025-12-29",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000646",
|
|
"occurrenceDate": "2024-11-30",
|
|
"registrationDate": "2024-12-10",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208107369",
|
|
"model": "HD-180",
|
|
"batchNo": "A4967946",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-12-16",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000647",
|
|
"occurrenceDate": "2025-11-18",
|
|
"registrationDate": "2025-11-27",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2016823604",
|
|
"model": "IS-7.0",
|
|
"batchNo": "E7346436",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-12-02",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000648",
|
|
"occurrenceDate": "2026-02-21",
|
|
"registrationDate": "2026-02-28",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016778033",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "G6691117",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2026-03-03",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000649",
|
|
"occurrenceDate": "2025-10-30",
|
|
"registrationDate": "2025-11-07",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019492339",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D6635559",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-11-11",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000650",
|
|
"occurrenceDate": "2025-06-27",
|
|
"registrationDate": "2025-07-06",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进205626956",
|
|
"model": "20ml Luer",
|
|
"batchNo": "H2461297",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000651",
|
|
"occurrenceDate": "2025-12-13",
|
|
"registrationDate": "2025-12-24",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进206140074",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "H9158718",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-12-31",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000652",
|
|
"occurrenceDate": "2026-03-28",
|
|
"registrationDate": "2026-04-04",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015644595",
|
|
"model": "IS-7.0",
|
|
"batchNo": "K9707295",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2026-04-07",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000653",
|
|
"occurrenceDate": "2024-12-09",
|
|
"registrationDate": "2024-12-18",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019137051",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J4973988",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-12-23",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000654",
|
|
"occurrenceDate": "2025-02-08",
|
|
"registrationDate": "2025-02-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208872993",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "F5626881",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-02-18",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000655",
|
|
"occurrenceDate": "2026-03-26",
|
|
"registrationDate": "2026-04-03",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2016833286",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "B1593539",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2026-04-07",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000656",
|
|
"occurrenceDate": "2024-01-23",
|
|
"registrationDate": "2024-01-26",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2016671141",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "J2087452",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-01-31",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000657",
|
|
"occurrenceDate": "2025-03-13",
|
|
"registrationDate": "2025-03-24",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准209289918",
|
|
"model": "4053000",
|
|
"batchNo": "F9579441",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-03-31",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000658",
|
|
"occurrenceDate": "2025-09-26",
|
|
"registrationDate": "2025-10-08",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进205403503",
|
|
"model": "BIC-35",
|
|
"batchNo": "H2374275",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-10-16",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000659",
|
|
"occurrenceDate": "2024-07-27",
|
|
"registrationDate": "2024-07-28",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准208366305",
|
|
"model": "EX-100cm",
|
|
"batchNo": "E3308323",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-07-31",
|
|
"province": "福建省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000660",
|
|
"occurrenceDate": "2024-12-14",
|
|
"registrationDate": "2024-12-22",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208104966",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "E4519770",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-12-26",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000661",
|
|
"occurrenceDate": "2024-01-22",
|
|
"registrationDate": "2024-01-23",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准208346916",
|
|
"model": "PF-7.0",
|
|
"batchNo": "J2892829",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000662",
|
|
"occurrenceDate": "2025-06-15",
|
|
"registrationDate": "2025-06-18",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2017738561",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "G3442227",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-06-23",
|
|
"province": "河南省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000663",
|
|
"occurrenceDate": "2024-01-15",
|
|
"registrationDate": "2024-01-26",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2016897962",
|
|
"model": "ACID-8L",
|
|
"batchNo": "K8471253",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-02-02",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000664",
|
|
"occurrenceDate": "2025-03-20",
|
|
"registrationDate": "2025-03-23",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018504997",
|
|
"model": "IS-5.0",
|
|
"batchNo": "D5654991",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000665",
|
|
"occurrenceDate": "2026-03-19",
|
|
"registrationDate": "2026-03-30",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进209699508",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "H8604398",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2026-04-06",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000666",
|
|
"occurrenceDate": "2023-12-01",
|
|
"registrationDate": "2023-12-07",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205445435",
|
|
"model": "4053000",
|
|
"batchNo": "C5015527",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2023-12-15",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000667",
|
|
"occurrenceDate": "2025-11-27",
|
|
"registrationDate": "2025-11-28",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019173790",
|
|
"model": "IS-5.0",
|
|
"batchNo": "B2007070",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-12-01",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000668",
|
|
"occurrenceDate": "2026-03-24",
|
|
"registrationDate": "2026-04-05",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准207357424",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "C6512830",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2026-04-13",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000669",
|
|
"occurrenceDate": "2024-01-06",
|
|
"registrationDate": "2024-01-16",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019700466",
|
|
"model": "4251624",
|
|
"batchNo": "B4557722",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-01-22",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000670",
|
|
"occurrenceDate": "2024-06-28",
|
|
"registrationDate": "2024-07-07",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准206230836",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E2369773",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-07-12",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000671",
|
|
"occurrenceDate": "2024-12-21",
|
|
"registrationDate": "2024-12-22",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进208301894",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "C4115792",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-12-25",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000672",
|
|
"occurrenceDate": "2024-04-26",
|
|
"registrationDate": "2024-04-30",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进205725456",
|
|
"model": "EX-100cm",
|
|
"batchNo": "D1886347",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-05-06",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000673",
|
|
"occurrenceDate": "2024-07-11",
|
|
"registrationDate": "2024-07-23",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206680620",
|
|
"model": "IS-7.0",
|
|
"batchNo": "K1233176",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-07-31",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000674",
|
|
"occurrenceDate": "2024-05-18",
|
|
"registrationDate": "2024-05-28",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2019492719",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "E3166374",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-06-03",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000675",
|
|
"occurrenceDate": "2024-09-26",
|
|
"registrationDate": "2024-10-04",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2016628386",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "F2562887",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2024-10-08",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000676",
|
|
"occurrenceDate": "2026-01-12",
|
|
"registrationDate": "2026-01-23",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206299933",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "F6380921",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2026-01-30",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000677",
|
|
"occurrenceDate": "2025-07-04",
|
|
"registrationDate": "2025-07-09",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2018508188",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "A5987661",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-07-16",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000678",
|
|
"occurrenceDate": "2024-08-21",
|
|
"registrationDate": "2024-08-29",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2015146113",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H2947080",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2024-09-02",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000679",
|
|
"occurrenceDate": "2024-09-19",
|
|
"registrationDate": "2024-09-20",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2019753608",
|
|
"model": "ACID-8L",
|
|
"batchNo": "K2307881",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-09-23",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000680",
|
|
"occurrenceDate": "2024-09-17",
|
|
"registrationDate": "2024-09-19",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2016411812",
|
|
"model": "EX-100cm",
|
|
"batchNo": "C6132930",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-09-23",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000681",
|
|
"occurrenceDate": "2025-04-25",
|
|
"registrationDate": "2025-05-01",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准207532387",
|
|
"model": "EX-100cm",
|
|
"batchNo": "A5120012",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-05-09",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000682",
|
|
"occurrenceDate": "2025-12-23",
|
|
"registrationDate": "2025-12-30",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207892573",
|
|
"model": "4053000",
|
|
"batchNo": "C5601311",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2026-01-02",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000683",
|
|
"occurrenceDate": "2025-03-28",
|
|
"registrationDate": "2025-04-06",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准209776349",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "G2411845",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-04-11",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000684",
|
|
"occurrenceDate": "2026-01-11",
|
|
"registrationDate": "2026-01-19",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016591775",
|
|
"model": "HD-180",
|
|
"batchNo": "D3137596",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2026-01-23",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000685",
|
|
"occurrenceDate": "2024-06-04",
|
|
"registrationDate": "2024-06-06",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205188385",
|
|
"model": "HD-180",
|
|
"batchNo": "A8413262",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-06-10",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000686",
|
|
"occurrenceDate": "2026-04-04",
|
|
"registrationDate": "2026-04-05",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2017123746",
|
|
"model": "PF-5.0",
|
|
"batchNo": "J3360371",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2026-04-08",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000687",
|
|
"occurrenceDate": "2024-01-16",
|
|
"registrationDate": "2024-01-20",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2019252220",
|
|
"model": "4053000",
|
|
"batchNo": "E1022306",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000688",
|
|
"occurrenceDate": "2024-10-21",
|
|
"registrationDate": "2024-10-22",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206510755",
|
|
"model": "EX-50cm",
|
|
"batchNo": "B2522143",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-10-25",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000689",
|
|
"occurrenceDate": "2026-03-20",
|
|
"registrationDate": "2026-03-28",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2017431869",
|
|
"model": "4251624",
|
|
"batchNo": "K9822927",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2026-04-01",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000690",
|
|
"occurrenceDate": "2024-02-21",
|
|
"registrationDate": "2024-02-23",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018359744",
|
|
"model": "4053000",
|
|
"batchNo": "C4099584",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-02-27",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000691",
|
|
"occurrenceDate": "2026-01-15",
|
|
"registrationDate": "2026-01-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209612306",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "A1214739",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2026-01-27",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000692",
|
|
"occurrenceDate": "2024-05-29",
|
|
"registrationDate": "2024-06-01",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2015360645",
|
|
"model": "EX-100cm",
|
|
"batchNo": "D9689039",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-06-06",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000693",
|
|
"occurrenceDate": "2026-03-20",
|
|
"registrationDate": "2026-03-26",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2015358514",
|
|
"model": "BIC-35",
|
|
"batchNo": "D1039506",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-04-03",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000694",
|
|
"occurrenceDate": "2024-09-21",
|
|
"registrationDate": "2024-09-28",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进209231691",
|
|
"model": "PF-5.0",
|
|
"batchNo": "G5805037",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-10-01",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000695",
|
|
"occurrenceDate": "2025-01-12",
|
|
"registrationDate": "2025-01-20",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准206696083",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "D7274585",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2025-01-24",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000696",
|
|
"occurrenceDate": "2026-02-10",
|
|
"registrationDate": "2026-02-14",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2015465752",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "B9435954",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2026-02-20",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000697",
|
|
"occurrenceDate": "2024-04-07",
|
|
"registrationDate": "2024-04-12",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207264045",
|
|
"model": "4251624",
|
|
"batchNo": "K3453692",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-04-19",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000698",
|
|
"occurrenceDate": "2025-06-27",
|
|
"registrationDate": "2025-07-06",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2017346100",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "K3453692",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "去除敷料时皮肤撕脱",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000699",
|
|
"occurrenceDate": "2024-03-05",
|
|
"registrationDate": "2024-03-07",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206344142",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "G7391655",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2024-03-11",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000700",
|
|
"occurrenceDate": "2024-11-24",
|
|
"registrationDate": "2024-12-04",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207711434",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "A3697502",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-12-10",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000701",
|
|
"occurrenceDate": "2024-01-06",
|
|
"registrationDate": "2024-01-18",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208995560",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "E3504282",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000702",
|
|
"occurrenceDate": "2026-04-04",
|
|
"registrationDate": "2026-04-06",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准205822152",
|
|
"model": "20ml Luer",
|
|
"batchNo": "D7140819",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2026-04-10",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000703",
|
|
"occurrenceDate": "2024-09-17",
|
|
"registrationDate": "2024-09-26",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2019142817",
|
|
"model": "BIC-35",
|
|
"batchNo": "E6260106",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-10-01",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000704",
|
|
"occurrenceDate": "2025-12-05",
|
|
"registrationDate": "2025-12-14",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018492188",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "B5315000",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2025-12-19",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000705",
|
|
"occurrenceDate": "2025-02-11",
|
|
"registrationDate": "2025-02-15",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016195287",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "F4863248",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-02-21",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000706",
|
|
"occurrenceDate": "2025-06-06",
|
|
"registrationDate": "2025-06-13",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018821505",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "D6958423",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-06-16",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000707",
|
|
"occurrenceDate": "2024-04-19",
|
|
"registrationDate": "2024-04-25",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进207777762",
|
|
"model": "HD-180",
|
|
"batchNo": "C9110550",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-05-03",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000708",
|
|
"occurrenceDate": "2026-01-31",
|
|
"registrationDate": "2026-02-07",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2017597429",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "B2401394",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2026-02-10",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000709",
|
|
"occurrenceDate": "2024-12-27",
|
|
"registrationDate": "2025-01-05",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2017160962",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "D7050174",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2025-01-10",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000710",
|
|
"occurrenceDate": "2025-11-18",
|
|
"registrationDate": "2025-11-25",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进208221305",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K3758950",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-11-28",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000711",
|
|
"occurrenceDate": "2024-09-08",
|
|
"registrationDate": "2024-09-16",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208891221",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J7066255",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000712",
|
|
"occurrenceDate": "2024-02-11",
|
|
"registrationDate": "2024-02-16",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2016327949",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F5806949",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2024-02-23",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000713",
|
|
"occurrenceDate": "2025-10-12",
|
|
"registrationDate": "2025-10-16",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207704752",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "B6689759",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-10-22",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000714",
|
|
"occurrenceDate": "2024-10-23",
|
|
"registrationDate": "2024-10-29",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准206512415",
|
|
"model": "IS-5.0",
|
|
"batchNo": "H5629879",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-11-06",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000715",
|
|
"occurrenceDate": "2024-06-11",
|
|
"registrationDate": "2024-06-18",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2017295502",
|
|
"model": "BIC-35",
|
|
"batchNo": "B8358414",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2024-06-21",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000716",
|
|
"occurrenceDate": "2026-01-17",
|
|
"registrationDate": "2026-01-22",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209653202",
|
|
"model": "4251625",
|
|
"batchNo": "K6524848",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2026-01-29",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000717",
|
|
"occurrenceDate": "2024-09-22",
|
|
"registrationDate": "2024-09-29",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205642231",
|
|
"model": "IS-5.0",
|
|
"batchNo": "H7351427",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-10-02",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000718",
|
|
"occurrenceDate": "2026-03-19",
|
|
"registrationDate": "2026-03-24",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207200846",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "H3398658",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2026-03-31",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000719",
|
|
"occurrenceDate": "2025-06-10",
|
|
"registrationDate": "2025-06-14",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2016551525",
|
|
"model": "PF-7.0",
|
|
"batchNo": "B7526241",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2025-06-20",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000720",
|
|
"occurrenceDate": "2025-09-12",
|
|
"registrationDate": "2025-09-17",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2016636629",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "F2496713",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2025-09-24",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000721",
|
|
"occurrenceDate": "2024-12-13",
|
|
"registrationDate": "2024-12-19",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准207751943",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "F6165859",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-12-27",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000722",
|
|
"occurrenceDate": "2023-12-14",
|
|
"registrationDate": "2023-12-16",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209684406",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "B1192462",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2023-12-20",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000723",
|
|
"occurrenceDate": "2024-03-13",
|
|
"registrationDate": "2024-03-22",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准206970349",
|
|
"model": "IS-7.0",
|
|
"batchNo": "K1037096",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-03-27",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000724",
|
|
"occurrenceDate": "2025-08-15",
|
|
"registrationDate": "2025-08-27",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207282686",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F6226590",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-09-04",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000725",
|
|
"occurrenceDate": "2025-03-13",
|
|
"registrationDate": "2025-03-16",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2015998131",
|
|
"model": "4053000",
|
|
"batchNo": "K9919311",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-03-21",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000726",
|
|
"occurrenceDate": "2024-01-26",
|
|
"registrationDate": "2024-02-01",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注进207360651",
|
|
"model": "10ml Luer",
|
|
"batchNo": "B3762163",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2024-02-09",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000727",
|
|
"occurrenceDate": "2024-03-06",
|
|
"registrationDate": "2024-03-09",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206796985",
|
|
"model": "EX-100cm",
|
|
"batchNo": "D9694667",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-03-14",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000728",
|
|
"occurrenceDate": "2026-01-09",
|
|
"registrationDate": "2026-01-18",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016876143",
|
|
"model": "4251624",
|
|
"batchNo": "G9240390",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2026-01-23",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000729",
|
|
"occurrenceDate": "2024-09-24",
|
|
"registrationDate": "2024-10-01",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2019614998",
|
|
"model": "PF-7.0",
|
|
"batchNo": "B8748434",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-10-04",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000730",
|
|
"occurrenceDate": "2025-04-26",
|
|
"registrationDate": "2025-05-07",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205194606",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H4796854",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-05-14",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000731",
|
|
"occurrenceDate": "2024-07-26",
|
|
"registrationDate": "2024-08-01",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2019983780",
|
|
"model": "HD-180",
|
|
"batchNo": "F2410640",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-08-09",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000732",
|
|
"occurrenceDate": "2024-02-11",
|
|
"registrationDate": "2024-02-12",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准205340438",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "E2603458",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-02-15",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000733",
|
|
"occurrenceDate": "2023-12-18",
|
|
"registrationDate": "2023-12-24",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准205296071",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "A7757546",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2024-01-01",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000734",
|
|
"occurrenceDate": "2024-03-16",
|
|
"registrationDate": "2024-03-27",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准208732700",
|
|
"model": "PF-5.0",
|
|
"batchNo": "K9402252",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-04-03",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000735",
|
|
"occurrenceDate": "2025-05-26",
|
|
"registrationDate": "2025-05-27",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准208328344",
|
|
"model": "EX-100cm",
|
|
"batchNo": "C4094432",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-05-30",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000736",
|
|
"occurrenceDate": "2024-07-24",
|
|
"registrationDate": "2024-08-05",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准207466262",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "A7307554",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-08-13",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000737",
|
|
"occurrenceDate": "2024-12-26",
|
|
"registrationDate": "2025-01-06",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准206204606",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "D8334115",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-01-13",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000738",
|
|
"occurrenceDate": "2024-10-28",
|
|
"registrationDate": "2024-11-01",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2017569513",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "K5168914",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-11-07",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000739",
|
|
"occurrenceDate": "2025-06-26",
|
|
"registrationDate": "2025-06-27",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进207374748",
|
|
"model": "ACID-8L",
|
|
"batchNo": "A6379486",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-06-30",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000740",
|
|
"occurrenceDate": "2025-03-02",
|
|
"registrationDate": "2025-03-07",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准209786435",
|
|
"model": "BIC-35",
|
|
"batchNo": "E9715733",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-03-14",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000741",
|
|
"occurrenceDate": "2024-08-28",
|
|
"registrationDate": "2024-08-31",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2017757706",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "B3467600",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-09-05",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000742",
|
|
"occurrenceDate": "2024-04-12",
|
|
"registrationDate": "2024-04-21",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准205752725",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E7541131",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-04-26",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000743",
|
|
"occurrenceDate": "2025-12-24",
|
|
"registrationDate": "2026-01-05",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2019290440",
|
|
"model": "ACID-8L",
|
|
"batchNo": "A9370492",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-01-13",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000744",
|
|
"occurrenceDate": "2024-05-16",
|
|
"registrationDate": "2024-05-18",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准207550752",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D3933855",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2024-05-22",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000745",
|
|
"occurrenceDate": "2024-01-03",
|
|
"registrationDate": "2024-01-13",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准206861357",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C3967047",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-01-19",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000746",
|
|
"occurrenceDate": "2025-07-04",
|
|
"registrationDate": "2025-07-05",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018479637",
|
|
"model": "4251625",
|
|
"batchNo": "C8206124",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-07-08",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000747",
|
|
"occurrenceDate": "2026-02-05",
|
|
"registrationDate": "2026-02-11",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进208378055",
|
|
"model": "BIC-35",
|
|
"batchNo": "E8864403",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2026-02-19",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000748",
|
|
"occurrenceDate": "2025-11-23",
|
|
"registrationDate": "2025-11-28",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209950143",
|
|
"model": "IS-5.0",
|
|
"batchNo": "H5701283",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-12-05",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000749",
|
|
"occurrenceDate": "2024-02-13",
|
|
"registrationDate": "2024-02-17",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206531014",
|
|
"model": "4251624",
|
|
"batchNo": "K5825570",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-02-23",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000750",
|
|
"occurrenceDate": "2024-05-06",
|
|
"registrationDate": "2024-05-15",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015676663",
|
|
"model": "4053000",
|
|
"batchNo": "J3078614",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2024-05-20",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000751",
|
|
"occurrenceDate": "2025-07-23",
|
|
"registrationDate": "2025-07-26",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017122783",
|
|
"model": "4251624",
|
|
"batchNo": "B3146205",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-07-31",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000752",
|
|
"occurrenceDate": "2024-10-19",
|
|
"registrationDate": "2024-10-20",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206913795",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "G9479660",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-10-23",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000753",
|
|
"occurrenceDate": "2024-01-08",
|
|
"registrationDate": "2024-01-19",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准209446750",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "D3279853",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-01-26",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000754",
|
|
"occurrenceDate": "2025-10-02",
|
|
"registrationDate": "2025-10-13",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2019208978",
|
|
"model": "EX-100cm",
|
|
"batchNo": "G8026477",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-10-20",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000755",
|
|
"occurrenceDate": "2024-07-16",
|
|
"registrationDate": "2024-07-23",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206407575",
|
|
"model": "PF-5.0",
|
|
"batchNo": "B7852349",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-07-26",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000756",
|
|
"occurrenceDate": "2025-03-22",
|
|
"registrationDate": "2025-03-29",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2015659311",
|
|
"model": "PF-5.0",
|
|
"batchNo": "C3376796",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-04-01",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000757",
|
|
"occurrenceDate": "2024-08-10",
|
|
"registrationDate": "2024-08-14",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进206819021",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "B9839934",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-08-20",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000758",
|
|
"occurrenceDate": "2024-06-07",
|
|
"registrationDate": "2024-06-14",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进206160225",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "D7224573",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-06-17",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000759",
|
|
"occurrenceDate": "2025-01-13",
|
|
"registrationDate": "2025-01-17",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进205249828",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "K6557697",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2025-01-23",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000760",
|
|
"occurrenceDate": "2025-05-18",
|
|
"registrationDate": "2025-05-25",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2019854851",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "E2743444",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2025-05-28",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000761",
|
|
"occurrenceDate": "2025-04-17",
|
|
"registrationDate": "2025-04-25",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准205165103",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "H8835437",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-04-29",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000762",
|
|
"occurrenceDate": "2026-01-08",
|
|
"registrationDate": "2026-01-11",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2017505645",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "E1533689",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2026-01-16",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000763",
|
|
"occurrenceDate": "2024-03-20",
|
|
"registrationDate": "2024-03-28",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准209733726",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E2103756",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2024-04-01",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000764",
|
|
"occurrenceDate": "2024-05-05",
|
|
"registrationDate": "2024-05-13",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2018851945",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "J3524849",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-05-17",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000765",
|
|
"occurrenceDate": "2024-02-20",
|
|
"registrationDate": "2024-02-27",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2016237623",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "J1321111",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2024-03-01",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000766",
|
|
"occurrenceDate": "2025-05-29",
|
|
"registrationDate": "2025-06-04",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2017819706",
|
|
"model": "10ml Luer",
|
|
"batchNo": "E9908364",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "针头与针座连接处渗漏",
|
|
"reviewDate": "2025-06-12",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000767",
|
|
"occurrenceDate": "2025-03-13",
|
|
"registrationDate": "2025-03-14",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208593215",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H2108104",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-03-17",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000768",
|
|
"occurrenceDate": "2026-01-06",
|
|
"registrationDate": "2026-01-10",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2017488646",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "K1478710",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2026-01-16",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000769",
|
|
"occurrenceDate": "2024-11-03",
|
|
"registrationDate": "2024-11-11",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018616459",
|
|
"model": "4053000",
|
|
"batchNo": "D8055816",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-11-15",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000770",
|
|
"occurrenceDate": "2025-05-20",
|
|
"registrationDate": "2025-05-30",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2015201401",
|
|
"model": "EX-100cm",
|
|
"batchNo": "E3915313",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-06-05",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000771",
|
|
"occurrenceDate": "2024-08-04",
|
|
"registrationDate": "2024-08-12",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205546435",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "F8181194",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-08-16",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000772",
|
|
"occurrenceDate": "2024-07-13",
|
|
"registrationDate": "2024-07-17",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准208976469",
|
|
"model": "EX-100cm",
|
|
"batchNo": "C8617190",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-07-23",
|
|
"province": "浙江省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000773",
|
|
"occurrenceDate": "2025-07-19",
|
|
"registrationDate": "2025-07-21",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进207133635",
|
|
"model": "EX-50cm",
|
|
"batchNo": "H9058046",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-07-25",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000774",
|
|
"occurrenceDate": "2024-02-17",
|
|
"registrationDate": "2024-02-25",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016682604",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "C6362825",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-02-29",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000775",
|
|
"occurrenceDate": "2023-12-15",
|
|
"registrationDate": "2023-12-16",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进205199076",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "E5342684",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2023-12-19",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000776",
|
|
"occurrenceDate": "2024-06-29",
|
|
"registrationDate": "2024-07-07",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进207652496",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "F6503692",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-07-11",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000777",
|
|
"occurrenceDate": "2025-01-12",
|
|
"registrationDate": "2025-01-13",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准208884243",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "C5656048",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-01-16",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000778",
|
|
"occurrenceDate": "2025-11-24",
|
|
"registrationDate": "2025-12-05",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2019767397",
|
|
"model": "EX-100cm",
|
|
"batchNo": "J5082963",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-12-12",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000779",
|
|
"occurrenceDate": "2025-05-18",
|
|
"registrationDate": "2025-05-19",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进206316847",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "K6898539",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-05-22",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000780",
|
|
"occurrenceDate": "2025-11-18",
|
|
"registrationDate": "2025-11-24",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进2017712309",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "D8185937",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-12-02",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000781",
|
|
"occurrenceDate": "2025-01-12",
|
|
"registrationDate": "2025-01-20",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准209101766",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "F2140785",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-01-24",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000782",
|
|
"occurrenceDate": "2024-11-10",
|
|
"registrationDate": "2024-11-18",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进205664725",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "D1779635",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2024-11-22",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000783",
|
|
"occurrenceDate": "2025-05-10",
|
|
"registrationDate": "2025-05-11",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016193152",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H5694910",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-05-14",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000784",
|
|
"occurrenceDate": "2026-04-03",
|
|
"registrationDate": "2026-04-04",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2018871273",
|
|
"model": "PF-7.0",
|
|
"batchNo": "J1634376",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2026-04-07",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000785",
|
|
"occurrenceDate": "2025-03-07",
|
|
"registrationDate": "2025-03-12",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准208880760",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "C6952435",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-03-19",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000786",
|
|
"occurrenceDate": "2024-05-31",
|
|
"registrationDate": "2024-06-12",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207949770",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E8722346",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2024-06-20",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000787",
|
|
"occurrenceDate": "2025-08-22",
|
|
"registrationDate": "2025-08-27",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017910344",
|
|
"model": "IS-7.0",
|
|
"batchNo": "J9044844",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-09-03",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000788",
|
|
"occurrenceDate": "2024-02-14",
|
|
"registrationDate": "2024-02-24",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2017898796",
|
|
"model": "EX-50cm",
|
|
"batchNo": "D1633038",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-03-01",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000789",
|
|
"occurrenceDate": "2024-05-19",
|
|
"registrationDate": "2024-05-29",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018447874",
|
|
"model": "4053000",
|
|
"batchNo": "K2918272",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-06-04",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000790",
|
|
"occurrenceDate": "2024-10-22",
|
|
"registrationDate": "2024-10-28",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2015910417",
|
|
"model": "HD-180",
|
|
"batchNo": "E5390945",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-11-05",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000791",
|
|
"occurrenceDate": "2024-06-30",
|
|
"registrationDate": "2024-07-01",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205232991",
|
|
"model": "4053000",
|
|
"batchNo": "K4515524",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2024-07-04",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000792",
|
|
"occurrenceDate": "2024-05-19",
|
|
"registrationDate": "2024-05-29",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进208628204",
|
|
"model": "PF-5.0",
|
|
"batchNo": "H8542147",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-06-04",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000793",
|
|
"occurrenceDate": "2024-09-17",
|
|
"registrationDate": "2024-09-29",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2016921734",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "J6158170",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-10-07",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000794",
|
|
"occurrenceDate": "2025-06-10",
|
|
"registrationDate": "2025-06-17",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进2016393202",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "F4059450",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2025-06-20",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000795",
|
|
"occurrenceDate": "2024-11-11",
|
|
"registrationDate": "2024-11-17",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019312500",
|
|
"model": "4251624",
|
|
"batchNo": "A3520263",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2024-11-25",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000796",
|
|
"occurrenceDate": "2024-03-29",
|
|
"registrationDate": "2024-03-30",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207700471",
|
|
"model": "4053000",
|
|
"batchNo": "F2555274",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-04-02",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000797",
|
|
"occurrenceDate": "2024-07-10",
|
|
"registrationDate": "2024-07-20",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准208628267",
|
|
"model": "EX-50cm",
|
|
"batchNo": "E9578022",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-07-26",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000798",
|
|
"occurrenceDate": "2026-02-04",
|
|
"registrationDate": "2026-02-14",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准208201536",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "E4015498",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "缝针与线体连接处松动",
|
|
"reviewDate": "2026-02-20",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000799",
|
|
"occurrenceDate": "2023-12-30",
|
|
"registrationDate": "2024-01-01",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2015616370",
|
|
"model": "4251624",
|
|
"batchNo": "A6681199",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-01-05",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000800",
|
|
"occurrenceDate": "2024-01-18",
|
|
"registrationDate": "2024-01-23",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016901956",
|
|
"model": "4053000",
|
|
"batchNo": "C8033571",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-01-30",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000801",
|
|
"occurrenceDate": "2024-07-12",
|
|
"registrationDate": "2024-07-21",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2016237905",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "E2292385",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-07-26",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000802",
|
|
"occurrenceDate": "2025-06-09",
|
|
"registrationDate": "2025-06-18",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2017480488",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "J2118477",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2025-06-23",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000803",
|
|
"occurrenceDate": "2024-02-23",
|
|
"registrationDate": "2024-02-27",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205529262",
|
|
"model": "4053000",
|
|
"batchNo": "K8986061",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-03-04",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000804",
|
|
"occurrenceDate": "2025-09-26",
|
|
"registrationDate": "2025-10-02",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2018661033",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "F1175090",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-10-10",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000805",
|
|
"occurrenceDate": "2025-09-27",
|
|
"registrationDate": "2025-10-09",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208913767",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "C9163642",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2025-10-17",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000806",
|
|
"occurrenceDate": "2024-02-12",
|
|
"registrationDate": "2024-02-23",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205666616",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H8206917",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-03-01",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000807",
|
|
"occurrenceDate": "2025-11-13",
|
|
"registrationDate": "2025-11-22",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019962383",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H4344073",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-11-27",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000808",
|
|
"occurrenceDate": "2026-03-28",
|
|
"registrationDate": "2026-04-02",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进207636145",
|
|
"model": "4251625",
|
|
"batchNo": "E8964375",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2026-04-09",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000809",
|
|
"occurrenceDate": "2024-09-29",
|
|
"registrationDate": "2024-10-09",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准207706447",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F8198447",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-10-15",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000810",
|
|
"occurrenceDate": "2025-04-18",
|
|
"registrationDate": "2025-04-26",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准208995522",
|
|
"model": "IS-7.0",
|
|
"batchNo": "E9816913",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-04-30",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000811",
|
|
"occurrenceDate": "2024-02-27",
|
|
"registrationDate": "2024-03-07",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019392956",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "D4188901",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-03-12",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000812",
|
|
"occurrenceDate": "2025-10-18",
|
|
"registrationDate": "2025-10-25",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2018760075",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "D7163051",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-10-28",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000813",
|
|
"occurrenceDate": "2026-01-30",
|
|
"registrationDate": "2026-02-05",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017747966",
|
|
"model": "IS-7.0",
|
|
"batchNo": "G7659153",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2026-02-13",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000814",
|
|
"occurrenceDate": "2025-02-01",
|
|
"registrationDate": "2025-02-03",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2018679754",
|
|
"model": "IS-5.0",
|
|
"batchNo": "J1827356",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-02-07",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000815",
|
|
"occurrenceDate": "2024-05-24",
|
|
"registrationDate": "2024-06-02",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207939985",
|
|
"model": "4053000",
|
|
"batchNo": "G5476103",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-06-07",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000816",
|
|
"occurrenceDate": "2024-04-01",
|
|
"registrationDate": "2024-04-08",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2015503987",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "H5243691",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2024-04-11",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000817",
|
|
"occurrenceDate": "2025-02-14",
|
|
"registrationDate": "2025-02-16",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准206872630",
|
|
"model": "4053000",
|
|
"batchNo": "G5193276",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-02-20",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000818",
|
|
"occurrenceDate": "2024-09-25",
|
|
"registrationDate": "2024-10-03",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205727465",
|
|
"model": "4053000",
|
|
"batchNo": "F4234282",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-10-07",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000819",
|
|
"occurrenceDate": "2024-07-26",
|
|
"registrationDate": "2024-07-28",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207913345",
|
|
"model": "4053000",
|
|
"batchNo": "G8263446",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-08-01",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000820",
|
|
"occurrenceDate": "2026-01-21",
|
|
"registrationDate": "2026-01-31",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015904407",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H9782598",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2026-02-06",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000821",
|
|
"occurrenceDate": "2025-06-27",
|
|
"registrationDate": "2025-07-03",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2016922675",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F2484392",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000822",
|
|
"occurrenceDate": "2026-01-14",
|
|
"registrationDate": "2026-01-26",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2019636881",
|
|
"model": "EX-100cm",
|
|
"batchNo": "H7021292",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2026-02-03",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000823",
|
|
"occurrenceDate": "2024-12-01",
|
|
"registrationDate": "2024-12-04",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进208995145",
|
|
"model": "PF-5.0",
|
|
"batchNo": "B1491410",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-12-09",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000824",
|
|
"occurrenceDate": "2025-03-10",
|
|
"registrationDate": "2025-03-21",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206823548",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "C4863341",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2025-03-28",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000825",
|
|
"occurrenceDate": "2026-03-25",
|
|
"registrationDate": "2026-03-31",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2018339368",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "D3656019",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2026-04-08",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000826",
|
|
"occurrenceDate": "2025-07-23",
|
|
"registrationDate": "2025-07-31",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2019237139",
|
|
"model": "IS-7.0",
|
|
"batchNo": "D1563297",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-08-04",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000827",
|
|
"occurrenceDate": "2026-03-07",
|
|
"registrationDate": "2026-03-11",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2017485486",
|
|
"model": "4251625",
|
|
"batchNo": "D3164708",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2026-03-17",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000828",
|
|
"occurrenceDate": "2025-11-12",
|
|
"registrationDate": "2025-11-15",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2016894761",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "D6322949",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2025-11-20",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000829",
|
|
"occurrenceDate": "2024-07-25",
|
|
"registrationDate": "2024-07-28",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进207829612",
|
|
"model": "EX-100cm",
|
|
"batchNo": "K1294607",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-08-02",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000830",
|
|
"occurrenceDate": "2025-03-16",
|
|
"registrationDate": "2025-03-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准206884274",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "F5206125",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-03-26",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000831",
|
|
"occurrenceDate": "2025-04-21",
|
|
"registrationDate": "2025-04-22",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205596733",
|
|
"model": "IS-7.0",
|
|
"batchNo": "F2838911",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2025-04-25",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000832",
|
|
"occurrenceDate": "2025-05-11",
|
|
"registrationDate": "2025-05-21",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2019747814",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "J6454416",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-05-27",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000833",
|
|
"occurrenceDate": "2024-05-25",
|
|
"registrationDate": "2024-06-06",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2017906823",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "B9437871",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-06-14",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000834",
|
|
"occurrenceDate": "2025-06-30",
|
|
"registrationDate": "2025-07-04",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2018861670",
|
|
"model": "10ml Luer",
|
|
"batchNo": "D9630909",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "推杆卡顿致推注阻力骤增",
|
|
"reviewDate": "2025-07-10",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000835",
|
|
"occurrenceDate": "2024-03-26",
|
|
"registrationDate": "2024-04-07",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207308640",
|
|
"model": "HD-180",
|
|
"batchNo": "F1246153",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-04-15",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000836",
|
|
"occurrenceDate": "2024-07-06",
|
|
"registrationDate": "2024-07-10",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207737544",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H2357770",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-07-16",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000837",
|
|
"occurrenceDate": "2025-01-23",
|
|
"registrationDate": "2025-02-01",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016459872",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "K2699571",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-02-06",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000838",
|
|
"occurrenceDate": "2026-02-20",
|
|
"registrationDate": "2026-02-21",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208778991",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "F3745346",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2026-02-24",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000839",
|
|
"occurrenceDate": "2025-09-25",
|
|
"registrationDate": "2025-09-28",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准206365279",
|
|
"model": "EX-50cm",
|
|
"batchNo": "H6244966",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-10-03",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000840",
|
|
"occurrenceDate": "2024-07-08",
|
|
"registrationDate": "2024-07-12",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准206465131",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "C7164988",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-07-18",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000841",
|
|
"occurrenceDate": "2025-01-25",
|
|
"registrationDate": "2025-01-26",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018751828",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "G6474204",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-01-29",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000842",
|
|
"occurrenceDate": "2025-02-11",
|
|
"registrationDate": "2025-02-15",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进209899877",
|
|
"model": "EX-50cm",
|
|
"batchNo": "J8266313",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-02-21",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000843",
|
|
"occurrenceDate": "2025-09-03",
|
|
"registrationDate": "2025-09-09",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2017533928",
|
|
"model": "EX-100cm",
|
|
"batchNo": "F4484611",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-09-17",
|
|
"province": "河南省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000844",
|
|
"occurrenceDate": "2026-01-12",
|
|
"registrationDate": "2026-01-22",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015123997",
|
|
"model": "4251625",
|
|
"batchNo": "C6281283",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2026-01-28",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000845",
|
|
"occurrenceDate": "2024-01-27",
|
|
"registrationDate": "2024-02-08",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016823399",
|
|
"model": "4251624",
|
|
"batchNo": "E4218572",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-02-16",
|
|
"province": "重庆市",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000846",
|
|
"occurrenceDate": "2024-05-27",
|
|
"registrationDate": "2024-06-06",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017204902",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H5890183",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2024-06-12",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000847",
|
|
"occurrenceDate": "2025-06-22",
|
|
"registrationDate": "2025-06-30",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209648658",
|
|
"model": "HD-180",
|
|
"batchNo": "F7009638",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-07-04",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000848",
|
|
"occurrenceDate": "2025-03-23",
|
|
"registrationDate": "2025-03-28",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2015170129",
|
|
"model": "HD-180",
|
|
"batchNo": "A1278866",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-04-04",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000849",
|
|
"occurrenceDate": "2025-09-30",
|
|
"registrationDate": "2025-10-10",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进205609744",
|
|
"model": "IS-7.0",
|
|
"batchNo": "E7016106",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2025-10-16",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000850",
|
|
"occurrenceDate": "2025-12-24",
|
|
"registrationDate": "2025-12-26",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进207483294",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C8198105",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-12-30",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000851",
|
|
"occurrenceDate": "2024-02-29",
|
|
"registrationDate": "2024-03-06",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准207895086",
|
|
"model": "PF-7.0",
|
|
"batchNo": "K1621072",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2024-03-14",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000852",
|
|
"occurrenceDate": "2024-10-16",
|
|
"registrationDate": "2024-10-19",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208393161",
|
|
"model": "4251624",
|
|
"batchNo": "F1405844",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-10-24",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000853",
|
|
"occurrenceDate": "2026-03-08",
|
|
"registrationDate": "2026-03-12",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2015135102",
|
|
"model": "ACID-8L",
|
|
"batchNo": "C5022547",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-03-18",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000854",
|
|
"occurrenceDate": "2025-12-09",
|
|
"registrationDate": "2025-12-13",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208950285",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "J7613360",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2025-12-19",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000855",
|
|
"occurrenceDate": "2024-05-23",
|
|
"registrationDate": "2024-05-24",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进207838291",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "K7279384",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-05-27",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000856",
|
|
"occurrenceDate": "2025-06-25",
|
|
"registrationDate": "2025-07-05",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2019871615",
|
|
"model": "IS-5.0",
|
|
"batchNo": "H1618226",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2025-07-11",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000857",
|
|
"occurrenceDate": "2024-02-05",
|
|
"registrationDate": "2024-02-16",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2019819074",
|
|
"model": "HD-180",
|
|
"batchNo": "D3938677",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2024-02-23",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000858",
|
|
"occurrenceDate": "2023-12-02",
|
|
"registrationDate": "2023-12-14",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2019795012",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "H3054506",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "泵管段磨损起皱",
|
|
"reviewDate": "2023-12-22",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000859",
|
|
"occurrenceDate": "2025-11-01",
|
|
"registrationDate": "2025-11-13",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进2017451499",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "G7713828",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-11-21",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000860",
|
|
"occurrenceDate": "2024-02-04",
|
|
"registrationDate": "2024-02-09",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准208252964",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "E6050629",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-02-16",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000861",
|
|
"occurrenceDate": "2024-08-15",
|
|
"registrationDate": "2024-08-21",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017359042",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "B4219706",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-08-29",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000862",
|
|
"occurrenceDate": "2025-11-23",
|
|
"registrationDate": "2025-12-04",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进205955881",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A9058272",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-12-11",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000863",
|
|
"occurrenceDate": "2025-05-03",
|
|
"registrationDate": "2025-05-05",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进205452031",
|
|
"model": "PF-5.0",
|
|
"batchNo": "F6754958",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-05-09",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000864",
|
|
"occurrenceDate": "2024-07-25",
|
|
"registrationDate": "2024-08-05",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准209602872",
|
|
"model": "EX-100cm",
|
|
"batchNo": "J6704170",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-08-12",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000865",
|
|
"occurrenceDate": "2024-06-11",
|
|
"registrationDate": "2024-06-17",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准2015308230",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "H6027704",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-06-25",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000866",
|
|
"occurrenceDate": "2025-02-13",
|
|
"registrationDate": "2025-02-16",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016805446",
|
|
"model": "HD-180",
|
|
"batchNo": "J1965266",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2025-02-21",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000867",
|
|
"occurrenceDate": "2025-06-07",
|
|
"registrationDate": "2025-06-12",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016561887",
|
|
"model": "IS-7.0",
|
|
"batchNo": "D8079131",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2025-06-19",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000868",
|
|
"occurrenceDate": "2024-04-29",
|
|
"registrationDate": "2024-05-10",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018161808",
|
|
"model": "HD-180",
|
|
"batchNo": "D8079131",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-05-17",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000869",
|
|
"occurrenceDate": "2025-03-24",
|
|
"registrationDate": "2025-04-03",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进209618022",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E4107549",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-04-09",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000870",
|
|
"occurrenceDate": "2025-11-07",
|
|
"registrationDate": "2025-11-19",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2017454225",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "C9489762",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2025-11-27",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000871",
|
|
"occurrenceDate": "2024-10-13",
|
|
"registrationDate": "2024-10-16",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2017675235",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "F5582625",
|
|
"injuryExpression": "腹胀",
|
|
"deviceFailure": "营养袋接口与泵管连接处渗漏",
|
|
"reviewDate": "2024-10-21",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000872",
|
|
"occurrenceDate": "2024-05-21",
|
|
"registrationDate": "2024-05-28",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2018504588",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "K9655959",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2024-05-31",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000873",
|
|
"occurrenceDate": "2024-04-15",
|
|
"registrationDate": "2024-04-19",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进207520707",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E6869605",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-04-25",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000874",
|
|
"occurrenceDate": "2025-04-07",
|
|
"registrationDate": "2025-04-13",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进207475651",
|
|
"model": "ACID-8L",
|
|
"batchNo": "C7794838",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-04-21",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000875",
|
|
"occurrenceDate": "2025-10-15",
|
|
"registrationDate": "2025-10-25",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2015424303",
|
|
"model": "ACID-8L",
|
|
"batchNo": "F9852240",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2025-10-31",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000876",
|
|
"occurrenceDate": "2025-09-27",
|
|
"registrationDate": "2025-09-29",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2018305135",
|
|
"model": "IS-7.0",
|
|
"batchNo": "H3516144",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-10-03",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000877",
|
|
"occurrenceDate": "2024-11-11",
|
|
"registrationDate": "2024-11-17",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2018806258",
|
|
"model": "IS-5.0",
|
|
"batchNo": "E4778618",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-11-25",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000878",
|
|
"occurrenceDate": "2025-08-23",
|
|
"registrationDate": "2025-09-04",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018216268",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "D5470397",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-09-12",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000879",
|
|
"occurrenceDate": "2025-02-05",
|
|
"registrationDate": "2025-02-08",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进2016599211",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "C4471085",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2025-02-13",
|
|
"province": "广东省",
|
|
"saeDeath": true,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000880",
|
|
"occurrenceDate": "2024-07-13",
|
|
"registrationDate": "2024-07-24",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017480842",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E3568041",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "回血观察窗模糊影响血流判断",
|
|
"reviewDate": "2024-07-31",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000881",
|
|
"occurrenceDate": "2025-07-25",
|
|
"registrationDate": "2025-07-29",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2016929336",
|
|
"model": "PF-5.0",
|
|
"batchNo": "J8712093",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-08-04",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000882",
|
|
"occurrenceDate": "2025-05-14",
|
|
"registrationDate": "2025-05-26",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2018482484",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "J4500993",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-06-03",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000883",
|
|
"occurrenceDate": "2023-12-20",
|
|
"registrationDate": "2023-12-26",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准206779350",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "J3105715",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-01-03",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000884",
|
|
"occurrenceDate": "2025-07-19",
|
|
"registrationDate": "2025-07-20",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准208336127",
|
|
"model": "PF-7.0",
|
|
"batchNo": "J8599340",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-07-23",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000885",
|
|
"occurrenceDate": "2025-07-10",
|
|
"registrationDate": "2025-07-19",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2015588395",
|
|
"model": "BIC-35",
|
|
"batchNo": "E3472863",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-07-24",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000886",
|
|
"occurrenceDate": "2024-02-25",
|
|
"registrationDate": "2024-02-29",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209907011",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "C8587058",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-03-06",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000887",
|
|
"occurrenceDate": "2024-04-20",
|
|
"registrationDate": "2024-04-25",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018784171",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "F1135859",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-05-02",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000888",
|
|
"occurrenceDate": "2023-12-15",
|
|
"registrationDate": "2023-12-24",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进2018293441",
|
|
"model": "EX-100cm",
|
|
"batchNo": "H9654634",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2023-12-29",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000889",
|
|
"occurrenceDate": "2024-02-16",
|
|
"registrationDate": "2024-02-22",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准205782292",
|
|
"model": "HD-180",
|
|
"batchNo": "E1741844",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-03-01",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000890",
|
|
"occurrenceDate": "2025-11-28",
|
|
"registrationDate": "2025-12-04",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进209262606",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "A7927201",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-12-12",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000891",
|
|
"occurrenceDate": "2026-01-22",
|
|
"registrationDate": "2026-01-24",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准208297905",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "D4627507",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2026-01-28",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000892",
|
|
"occurrenceDate": "2025-07-21",
|
|
"registrationDate": "2025-07-24",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准209837093",
|
|
"model": "BIC-35",
|
|
"batchNo": "E2336482",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2025-07-29",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000893",
|
|
"occurrenceDate": "2025-11-23",
|
|
"registrationDate": "2025-11-27",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准205518228",
|
|
"model": "PF-7.0",
|
|
"batchNo": "E3931099",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-12-03",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000894",
|
|
"occurrenceDate": "2024-06-20",
|
|
"registrationDate": "2024-06-29",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进209313204",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "K7429609",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2024-07-04",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000895",
|
|
"occurrenceDate": "2025-08-26",
|
|
"registrationDate": "2025-08-30",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进207122967",
|
|
"model": "BIC-35",
|
|
"batchNo": "H5480394",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2025-09-05",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000896",
|
|
"occurrenceDate": "2025-09-26",
|
|
"registrationDate": "2025-10-05",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2016963548",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "E5013802",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2025-10-10",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000897",
|
|
"occurrenceDate": "2024-05-02",
|
|
"registrationDate": "2024-05-08",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准205258286",
|
|
"model": "AV-SET-P",
|
|
"batchNo": "J1723391",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-05-16",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000898",
|
|
"occurrenceDate": "2025-12-17",
|
|
"registrationDate": "2025-12-26",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准208439080",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "H5852385",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2025-12-31",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000899",
|
|
"occurrenceDate": "2026-03-14",
|
|
"registrationDate": "2026-03-16",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017800559",
|
|
"model": "4053000",
|
|
"batchNo": "B1609251",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2026-03-20",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000900",
|
|
"occurrenceDate": "2024-12-10",
|
|
"registrationDate": "2024-12-17",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018835969",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "H2360867",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-12-20",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000901",
|
|
"occurrenceDate": "2025-09-27",
|
|
"registrationDate": "2025-10-07",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准206229733",
|
|
"model": "BIC-35",
|
|
"batchNo": "D2523116",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2025-10-13",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000902",
|
|
"occurrenceDate": "2026-02-11",
|
|
"registrationDate": "2026-02-21",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进206958330",
|
|
"model": "BIC-35",
|
|
"batchNo": "A7828765",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "透析液成分配比异常相关不适",
|
|
"reviewDate": "2026-02-27",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000903",
|
|
"occurrenceDate": "2024-10-22",
|
|
"registrationDate": "2024-10-26",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准206325009",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "B2456105",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2024-11-01",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000904",
|
|
"occurrenceDate": "2024-08-31",
|
|
"registrationDate": "2024-09-12",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2019775612",
|
|
"model": "EX-50cm",
|
|
"batchNo": "D3234745",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000905",
|
|
"occurrenceDate": "2024-04-21",
|
|
"registrationDate": "2024-04-25",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209520829",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "G6231154",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "针尖保护装置回弹不畅",
|
|
"reviewDate": "2024-05-01",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000906",
|
|
"occurrenceDate": "2025-06-24",
|
|
"registrationDate": "2025-06-28",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进207230993",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "E7768475",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-07-04",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000907",
|
|
"occurrenceDate": "2024-06-10",
|
|
"registrationDate": "2024-06-17",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206293184",
|
|
"model": "PF-5.0",
|
|
"batchNo": "K4499294",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2024-06-20",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000908",
|
|
"occurrenceDate": "2024-04-07",
|
|
"registrationDate": "2024-04-15",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207307932",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "A9668382",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-04-19",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000909",
|
|
"occurrenceDate": "2025-03-04",
|
|
"registrationDate": "2025-03-08",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2016100467",
|
|
"model": "4053000",
|
|
"batchNo": "A9820599",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-03-14",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000910",
|
|
"occurrenceDate": "2025-05-29",
|
|
"registrationDate": "2025-06-07",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2017947571",
|
|
"model": "4251624",
|
|
"batchNo": "J4234572",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-06-12",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000911",
|
|
"occurrenceDate": "2024-07-23",
|
|
"registrationDate": "2024-08-04",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206439260",
|
|
"model": "IS-7.0",
|
|
"batchNo": "A5253657",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-08-12",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000912",
|
|
"occurrenceDate": "2024-02-24",
|
|
"registrationDate": "2024-02-26",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2018619955",
|
|
"model": "IS-5.0",
|
|
"batchNo": "A2559485",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-03-01",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000913",
|
|
"occurrenceDate": "2024-11-07",
|
|
"registrationDate": "2024-11-16",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进206619005",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E9997327",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2024-11-21",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000914",
|
|
"occurrenceDate": "2024-05-26",
|
|
"registrationDate": "2024-06-05",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进208136184",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "A1970883",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2024-06-11",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000915",
|
|
"occurrenceDate": "2024-09-01",
|
|
"registrationDate": "2024-09-11",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207110531",
|
|
"model": "IS-7.0",
|
|
"batchNo": "A5401310",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2024-09-17",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000916",
|
|
"occurrenceDate": "2024-02-04",
|
|
"registrationDate": "2024-02-05",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准209299469",
|
|
"model": "PF-5.0",
|
|
"batchNo": "D8631113",
|
|
"injuryExpression": "胸闷",
|
|
"deviceFailure": "侧孔进气不畅",
|
|
"reviewDate": "2024-02-08",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000917",
|
|
"occurrenceDate": "2026-01-26",
|
|
"registrationDate": "2026-01-27",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准2019423608",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "D3126899",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2026-01-30",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000918",
|
|
"occurrenceDate": "2024-01-11",
|
|
"registrationDate": "2024-01-22",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207609490",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "B9091015",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2024-01-29",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000919",
|
|
"occurrenceDate": "2025-07-23",
|
|
"registrationDate": "2025-08-02",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2015802481",
|
|
"model": "EX-100cm",
|
|
"batchNo": "H4625852",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2025-08-08",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000920",
|
|
"occurrenceDate": "2025-01-28",
|
|
"registrationDate": "2025-02-04",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进209757344",
|
|
"model": "4251625",
|
|
"batchNo": "J2048444",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2025-02-07",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000921",
|
|
"occurrenceDate": "2024-06-17",
|
|
"registrationDate": "2024-06-27",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018166133",
|
|
"model": "HD-180",
|
|
"batchNo": "J2682161",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2024-07-03",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000922",
|
|
"occurrenceDate": "2025-03-11",
|
|
"registrationDate": "2025-03-23",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准206383953",
|
|
"model": "HD-180",
|
|
"batchNo": "D8198225",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-03-31",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000923",
|
|
"occurrenceDate": "2025-10-07",
|
|
"registrationDate": "2025-10-14",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016934080",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A7534065",
|
|
"injuryExpression": "透析中低血压",
|
|
"deviceFailure": "跨膜压波动偏大",
|
|
"reviewDate": "2025-10-17",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000924",
|
|
"occurrenceDate": "2024-07-23",
|
|
"registrationDate": "2024-07-29",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准208284914",
|
|
"model": "PF-7.0",
|
|
"batchNo": "C8532252",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2024-08-06",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000925",
|
|
"occurrenceDate": "2024-01-01",
|
|
"registrationDate": "2024-01-02",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208326485",
|
|
"model": "HD-180",
|
|
"batchNo": "C3023122",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-01-05",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000926",
|
|
"occurrenceDate": "2024-01-24",
|
|
"registrationDate": "2024-01-27",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进205534193",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E1203121",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2024-02-01",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000927",
|
|
"occurrenceDate": "2024-05-14",
|
|
"registrationDate": "2024-05-18",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进2015620262",
|
|
"model": "BIC-35",
|
|
"batchNo": "G9857974",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2024-05-24",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000928",
|
|
"occurrenceDate": "2026-02-19",
|
|
"registrationDate": "2026-02-24",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进208297531",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "C9127430",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "超滤率设置与监测不一致",
|
|
"reviewDate": "2026-03-03",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000929",
|
|
"occurrenceDate": "2024-07-21",
|
|
"registrationDate": "2024-07-26",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准207359198",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "D6734227",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "线体断裂残留",
|
|
"reviewDate": "2024-08-02",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000930",
|
|
"occurrenceDate": "2023-12-12",
|
|
"registrationDate": "2023-12-14",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进208920026",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "H3233583",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "采血后桡动脉痉挛",
|
|
"reviewDate": "2023-12-18",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000931",
|
|
"occurrenceDate": "2024-03-23",
|
|
"registrationDate": "2024-03-27",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2015746571",
|
|
"model": "ACID-8L",
|
|
"batchNo": "B3912292",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2024-04-02",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000932",
|
|
"occurrenceDate": "2024-03-09",
|
|
"registrationDate": "2024-03-11",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准2017323755",
|
|
"model": "OP-FILM-45",
|
|
"batchNo": "A8745468",
|
|
"injuryExpression": "皮肤红斑",
|
|
"deviceFailure": "粘性不足边缘翘起",
|
|
"reviewDate": "2024-03-15",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000933",
|
|
"occurrenceDate": "2024-06-28",
|
|
"registrationDate": "2024-07-07",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2015507315",
|
|
"model": "EX-50cm",
|
|
"batchNo": "A5446501",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2024-07-12",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000934",
|
|
"occurrenceDate": "2024-08-01",
|
|
"registrationDate": "2024-08-03",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注进206492601",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "H4115938",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2024-08-07",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000935",
|
|
"occurrenceDate": "2026-02-20",
|
|
"registrationDate": "2026-03-03",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准209763187",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "D3630850",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2026-03-10",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000936",
|
|
"occurrenceDate": "2025-10-04",
|
|
"registrationDate": "2025-10-08",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进209419870",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "K1456975",
|
|
"injuryExpression": "疼痛",
|
|
"deviceFailure": "缝针弯曲",
|
|
"reviewDate": "2025-10-14",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000937",
|
|
"occurrenceDate": "2025-07-04",
|
|
"registrationDate": "2025-07-11",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准205580410",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "B3083279",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2025-07-14",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000938",
|
|
"occurrenceDate": "2026-01-07",
|
|
"registrationDate": "2026-01-19",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准209491922",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "D6184531",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "肝素帽旋紧后微量渗液",
|
|
"reviewDate": "2026-01-27",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000939",
|
|
"occurrenceDate": "2025-12-19",
|
|
"registrationDate": "2025-12-27",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207896604",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "A6243287",
|
|
"injuryExpression": "胸痛",
|
|
"deviceFailure": "静脉压升高报警",
|
|
"reviewDate": "2025-12-31",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000940",
|
|
"occurrenceDate": "2026-01-01",
|
|
"registrationDate": "2026-01-07",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2018355879",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "H3810968",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "透析液侧压力传感器报警",
|
|
"reviewDate": "2026-01-15",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000941",
|
|
"occurrenceDate": "2025-08-11",
|
|
"registrationDate": "2025-08-12",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准206306529",
|
|
"model": "Premilene 3-0",
|
|
"batchNo": "A9352308",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2025-08-15",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000942",
|
|
"occurrenceDate": "2024-03-31",
|
|
"registrationDate": "2024-04-05",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用无菌注射器",
|
|
"registrationNo": "国械注准2019469450",
|
|
"model": "20ml Luer",
|
|
"batchNo": "C2103684",
|
|
"injuryExpression": "给药剂量偏差相关不适",
|
|
"deviceFailure": "刻度印刷模糊",
|
|
"reviewDate": "2024-04-12",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000943",
|
|
"occurrenceDate": "2024-04-01",
|
|
"registrationDate": "2024-04-12",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018483056",
|
|
"model": "EX-50cm",
|
|
"batchNo": "A6633013",
|
|
"injuryExpression": "药物输注延迟",
|
|
"deviceFailure": "延长管扭转触发流量报警",
|
|
"reviewDate": "2024-04-19",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000944",
|
|
"occurrenceDate": "2025-03-29",
|
|
"registrationDate": "2025-04-10",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准2016690779",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "A6304683",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-04-18",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000945",
|
|
"occurrenceDate": "2025-12-27",
|
|
"registrationDate": "2026-01-08",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注准2017545660",
|
|
"model": "BIC-35",
|
|
"batchNo": "C2769027",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "浓缩液桶盖密封条变形渗漏",
|
|
"reviewDate": "2026-01-16",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000946",
|
|
"occurrenceDate": "2025-07-21",
|
|
"registrationDate": "2025-07-31",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进2018221933",
|
|
"model": "PF-7.0",
|
|
"batchNo": "A6571173",
|
|
"injuryExpression": "低血压",
|
|
"deviceFailure": "过滤膜侧压力升高致滴速骤降",
|
|
"reviewDate": "2025-08-06",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000947",
|
|
"occurrenceDate": "2025-12-11",
|
|
"registrationDate": "2025-12-22",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207484540",
|
|
"model": "IS-5.0",
|
|
"batchNo": "G6078290",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-12-29",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000948",
|
|
"occurrenceDate": "2025-08-27",
|
|
"registrationDate": "2025-09-06",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注准208259322",
|
|
"model": "Novosyn 3-0",
|
|
"batchNo": "F1665418",
|
|
"injuryExpression": "切口裂开",
|
|
"deviceFailure": "缝线结滑脱",
|
|
"reviewDate": "2025-09-12",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000949",
|
|
"occurrenceDate": "2026-01-26",
|
|
"registrationDate": "2026-01-29",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准205986635",
|
|
"model": "EX-100cm",
|
|
"batchNo": "K2794882",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2026-02-03",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000950",
|
|
"occurrenceDate": "2024-05-22",
|
|
"registrationDate": "2024-05-27",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进206542116",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "E5701439",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-06-03",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": true,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000951",
|
|
"occurrenceDate": "2024-01-13",
|
|
"registrationDate": "2024-01-24",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "可吸收性外科缝线",
|
|
"registrationNo": "国械注进209580523",
|
|
"model": "Monosyn 4-0",
|
|
"batchNo": "E6302625",
|
|
"injuryExpression": "感染征象",
|
|
"deviceFailure": "缝线张力过早丧失",
|
|
"reviewDate": "2024-01-31",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000952",
|
|
"occurrenceDate": "2025-11-21",
|
|
"registrationDate": "2025-11-26",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206940170",
|
|
"model": "IS-5.0",
|
|
"batchNo": "H5765285",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2025-12-03",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000953",
|
|
"occurrenceDate": "2024-06-19",
|
|
"registrationDate": "2024-06-29",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进206634636",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "F5391894",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2024-07-05",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000954",
|
|
"occurrenceDate": "2024-02-01",
|
|
"registrationDate": "2024-02-04",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2015896591",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "E7748332",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2024-02-09",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000955",
|
|
"occurrenceDate": "2025-06-13",
|
|
"registrationDate": "2025-06-14",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2019780948",
|
|
"model": "IS-7.0",
|
|
"batchNo": "D3142628",
|
|
"injuryExpression": "心悸",
|
|
"deviceFailure": "流量调节轮锁止不良",
|
|
"reviewDate": "2025-06-17",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000956",
|
|
"occurrenceDate": "2025-12-19",
|
|
"registrationDate": "2025-12-21",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准205314780",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "H9771334",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2025-12-25",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000957",
|
|
"occurrenceDate": "2024-07-07",
|
|
"registrationDate": "2024-07-15",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注准209261312",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "F6521245",
|
|
"injuryExpression": "红斑",
|
|
"deviceFailure": "缝线表面粗糙刺激",
|
|
"reviewDate": "2024-07-19",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000958",
|
|
"occurrenceDate": "2024-09-11",
|
|
"registrationDate": "2024-09-21",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注准206640870",
|
|
"model": "SAFE-ABG",
|
|
"batchNo": "F6083928",
|
|
"injuryExpression": "血肿",
|
|
"deviceFailure": "针头保护套脱落困难",
|
|
"reviewDate": "2024-09-27",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000959",
|
|
"occurrenceDate": "2024-10-26",
|
|
"registrationDate": "2024-10-27",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进205556623",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "D9321857",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "管路预冲残留气泡",
|
|
"reviewDate": "2024-10-30",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000960",
|
|
"occurrenceDate": "2025-02-10",
|
|
"registrationDate": "2025-02-21",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "非吸收性外科缝线",
|
|
"registrationNo": "国械注进209928221",
|
|
"model": "Dafilon 5-0",
|
|
"batchNo": "G6276244",
|
|
"injuryExpression": "异物感",
|
|
"deviceFailure": "线结切割组织",
|
|
"reviewDate": "2025-02-28",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000961",
|
|
"occurrenceDate": "2024-09-27",
|
|
"registrationDate": "2024-10-09",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进206902879",
|
|
"model": "IS-5.0",
|
|
"batchNo": "B4588537",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2024-10-17",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000962",
|
|
"occurrenceDate": "2024-09-16",
|
|
"registrationDate": "2024-09-17",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进207871411",
|
|
"model": "IS-5.0",
|
|
"batchNo": "C4804594",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-09-20",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000963",
|
|
"occurrenceDate": "2025-07-23",
|
|
"registrationDate": "2025-08-02",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2018639749",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "C4984945",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-08-08",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000964",
|
|
"occurrenceDate": "2024-02-23",
|
|
"registrationDate": "2024-02-29",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017658287",
|
|
"model": "IS-7.0",
|
|
"batchNo": "A8518116",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "精密过滤器外壳裂纹",
|
|
"reviewDate": "2024-03-08",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000965",
|
|
"occurrenceDate": "2024-05-02",
|
|
"registrationDate": "2024-05-05",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准209508074",
|
|
"model": "EN-SET-1.2",
|
|
"batchNo": "G8376368",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-05-10",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000966",
|
|
"occurrenceDate": "2024-07-04",
|
|
"registrationDate": "2024-07-13",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注进205972374",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "D8575269",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "滴速传感器识别不稳定",
|
|
"reviewDate": "2024-07-18",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000967",
|
|
"occurrenceDate": "2026-03-25",
|
|
"registrationDate": "2026-03-27",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "诊断/监测耗材",
|
|
"productName": "一次性使用动脉采血器",
|
|
"registrationNo": "国械注进2019119118",
|
|
"model": "ABG-3ml",
|
|
"batchNo": "G4333947",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "肝素化不足标本凝固需重新采血",
|
|
"reviewDate": "2026-03-31",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000968",
|
|
"occurrenceDate": "2024-12-01",
|
|
"registrationDate": "2024-12-09",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准209718125",
|
|
"model": "EX-100cm",
|
|
"batchNo": "E8464297",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-12-13",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000969",
|
|
"occurrenceDate": "2024-03-22",
|
|
"registrationDate": "2024-03-24",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准207758905",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "B4416569",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2024-03-28",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000970",
|
|
"occurrenceDate": "2025-05-08",
|
|
"registrationDate": "2025-05-17",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进206390604",
|
|
"model": "PF-7.0",
|
|
"batchNo": "F8041164",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-05-22",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000971",
|
|
"occurrenceDate": "2026-02-21",
|
|
"registrationDate": "2026-02-26",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019301960",
|
|
"model": "4053000",
|
|
"batchNo": "E4286853",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2026-03-05",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000972",
|
|
"occurrenceDate": "2024-12-20",
|
|
"registrationDate": "2024-12-29",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注进205831781",
|
|
"model": "EX-100cm",
|
|
"batchNo": "E7424278",
|
|
"injuryExpression": "局部肿胀",
|
|
"deviceFailure": "接口渗液",
|
|
"reviewDate": "2025-01-03",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000973",
|
|
"occurrenceDate": "2024-07-01",
|
|
"registrationDate": "2024-07-02",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注进2019595060",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "K9090226",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-07-05",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000974",
|
|
"occurrenceDate": "2025-01-05",
|
|
"registrationDate": "2025-01-15",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2016360778",
|
|
"model": "Introcan Safety 20G",
|
|
"batchNo": "K5909283",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2025-01-21",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000975",
|
|
"occurrenceDate": "2025-09-26",
|
|
"registrationDate": "2025-10-05",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019284431",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "H9990336",
|
|
"injuryExpression": "穿刺部位疼痛",
|
|
"deviceFailure": "套管与导管座连接处渗漏",
|
|
"reviewDate": "2025-10-10",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000976",
|
|
"occurrenceDate": "2024-04-12",
|
|
"registrationDate": "2024-04-24",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205763692",
|
|
"model": "4251625",
|
|
"batchNo": "D3811673",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-05-02",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000977",
|
|
"occurrenceDate": "2025-02-12",
|
|
"registrationDate": "2025-02-21",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注进2016268425",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "A5276614",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-02-26",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000978",
|
|
"occurrenceDate": "2025-04-24",
|
|
"registrationDate": "2025-05-03",
|
|
"unitName": "华中科技大学同济医学院附属协和医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准209514514",
|
|
"model": "PF-5.0",
|
|
"batchNo": "C3471160",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-05-08",
|
|
"province": "湖北省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000979",
|
|
"occurrenceDate": "2025-05-18",
|
|
"registrationDate": "2025-05-21",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注进2017931383",
|
|
"model": "IS-7.0",
|
|
"batchNo": "E5582851",
|
|
"injuryExpression": "寒战",
|
|
"deviceFailure": "输液管路可见异物附着",
|
|
"reviewDate": "2025-05-26",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000980",
|
|
"occurrenceDate": "2025-03-11",
|
|
"registrationDate": "2025-03-21",
|
|
"unitName": "南京鼓楼医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准207107921",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "H2789454",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-03-27",
|
|
"province": "江苏省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000981",
|
|
"occurrenceDate": "2025-02-03",
|
|
"registrationDate": "2025-02-10",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注进209725607",
|
|
"model": "PF-7.0",
|
|
"batchNo": "F3439641",
|
|
"injuryExpression": "发热",
|
|
"deviceFailure": "过滤器下游管路温度异常升高",
|
|
"reviewDate": "2025-02-13",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000982",
|
|
"occurrenceDate": "2025-08-24",
|
|
"registrationDate": "2025-08-29",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准2018704349",
|
|
"model": "EX-50cm",
|
|
"batchNo": "B3868877",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2025-09-05",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000983",
|
|
"occurrenceDate": "2025-08-17",
|
|
"registrationDate": "2025-08-24",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208928376",
|
|
"model": "Diacap 1.4",
|
|
"batchNo": "H9162937",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2025-08-27",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000984",
|
|
"occurrenceDate": "2024-08-18",
|
|
"registrationDate": "2024-08-23",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准208903422",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "A6129437",
|
|
"injuryExpression": "出血",
|
|
"deviceFailure": "动脉端管路接头渗液",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000985",
|
|
"occurrenceDate": "2024-11-14",
|
|
"registrationDate": "2024-11-26",
|
|
"unitName": "浙江大学医学院附属第二医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2019447546",
|
|
"model": "IS-7.0",
|
|
"batchNo": "B9439104",
|
|
"injuryExpression": "空气栓塞相关症状（已处理）",
|
|
"deviceFailure": "管路接头松动致滴管内进气",
|
|
"reviewDate": "2024-12-04",
|
|
"province": "浙江省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000986",
|
|
"occurrenceDate": "2025-06-27",
|
|
"registrationDate": "2025-06-29",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析浓缩液",
|
|
"registrationNo": "国械注进205316196",
|
|
"model": "BIC-35",
|
|
"batchNo": "J5704878",
|
|
"injuryExpression": "呕吐",
|
|
"deviceFailure": "电导度监测短暂漂移",
|
|
"reviewDate": "2025-07-03",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000987",
|
|
"occurrenceDate": "2024-03-09",
|
|
"registrationDate": "2024-03-21",
|
|
"unitName": "西安交通大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2019241311",
|
|
"model": "4251624",
|
|
"batchNo": "G8803917",
|
|
"injuryExpression": "水肿",
|
|
"deviceFailure": "留置针固定翼粘贴失效",
|
|
"reviewDate": "2024-03-29",
|
|
"province": "陕西省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000988",
|
|
"occurrenceDate": "2025-01-04",
|
|
"registrationDate": "2025-01-12",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注准2016911246",
|
|
"model": "Diacap Pro 1.3",
|
|
"batchNo": "B8619211",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2025-01-16",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": true
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000989",
|
|
"occurrenceDate": "2025-11-20",
|
|
"registrationDate": "2025-11-23",
|
|
"unitName": "广东省人民医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析器",
|
|
"registrationNo": "国械注进2018268203",
|
|
"model": "HD-180",
|
|
"batchNo": "J5672855",
|
|
"injuryExpression": "肌肉痉挛",
|
|
"deviceFailure": "透析器外壳细微裂纹",
|
|
"reviewDate": "2025-11-28",
|
|
"province": "广东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000990",
|
|
"occurrenceDate": "2025-01-28",
|
|
"registrationDate": "2025-02-03",
|
|
"unitName": "上海市第一人民医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准205409954",
|
|
"model": "4251625",
|
|
"batchNo": "E1266590",
|
|
"injuryExpression": "静脉炎",
|
|
"deviceFailure": "导管腔内回血阻力增高",
|
|
"reviewDate": "2025-02-11",
|
|
"province": "上海市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000991",
|
|
"occurrenceDate": "2024-08-26",
|
|
"registrationDate": "2024-09-01",
|
|
"unitName": "中国医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输注延长管",
|
|
"registrationNo": "国械注准209527100",
|
|
"model": "EX-50cm",
|
|
"batchNo": "G9858929",
|
|
"injuryExpression": "输注中断相关焦虑",
|
|
"deviceFailure": "螺旋接口与泵管不匹配",
|
|
"reviewDate": "2024-09-09",
|
|
"province": "辽宁省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000992",
|
|
"occurrenceDate": "2025-11-17",
|
|
"registrationDate": "2025-11-27",
|
|
"unitName": "四川大学华西医院",
|
|
"businessUnit": "外科产品",
|
|
"productName": "一次性使用无菌手术膜",
|
|
"registrationNo": "国械注准206674870",
|
|
"model": "OP-FILM-60",
|
|
"batchNo": "C9382979",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "敷料下汗液积聚刺激",
|
|
"reviewDate": "2025-12-03",
|
|
"province": "四川省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000993",
|
|
"occurrenceDate": "2025-10-11",
|
|
"registrationDate": "2025-10-13",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018734777",
|
|
"model": "4251624",
|
|
"batchNo": "K9882995",
|
|
"injuryExpression": "局部感染征象",
|
|
"deviceFailure": "三通接头裂纹",
|
|
"reviewDate": "2025-10-17",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000994",
|
|
"occurrenceDate": "2025-01-23",
|
|
"registrationDate": "2025-01-31",
|
|
"unitName": "中南大学湘雅医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用精密过滤输液器",
|
|
"registrationNo": "国械注准2016778532",
|
|
"model": "PF-7.0",
|
|
"batchNo": "A8820564",
|
|
"injuryExpression": "头痛",
|
|
"deviceFailure": "排气孔堵塞需二次排气",
|
|
"reviewDate": "2025-02-04",
|
|
"province": "湖南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000995",
|
|
"occurrenceDate": "2024-10-26",
|
|
"registrationDate": "2024-10-27",
|
|
"unitName": "重庆医科大学附属第一医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用静脉留置针",
|
|
"registrationNo": "国械注准2018717660",
|
|
"model": "Introcan 18G",
|
|
"batchNo": "J9861695",
|
|
"injuryExpression": "瘙痒",
|
|
"deviceFailure": "延长管打折致滴速下降",
|
|
"reviewDate": "2024-10-30",
|
|
"province": "重庆市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000996",
|
|
"occurrenceDate": "2024-08-20",
|
|
"registrationDate": "2024-08-24",
|
|
"unitName": "福建省立医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准207335947",
|
|
"model": "IS-7.0",
|
|
"batchNo": "A8598480",
|
|
"injuryExpression": "渗漏致皮肤红斑",
|
|
"deviceFailure": "穿刺器与药瓶胶塞密封不严",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "福建省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000997",
|
|
"occurrenceDate": "2024-08-18",
|
|
"registrationDate": "2024-08-26",
|
|
"unitName": "郑州大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2017182503",
|
|
"model": "4053000",
|
|
"batchNo": "J7354708",
|
|
"injuryExpression": "恶心",
|
|
"deviceFailure": "滴速过快相关不适",
|
|
"reviewDate": "2024-08-30",
|
|
"province": "河南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000998",
|
|
"occurrenceDate": "2025-06-16",
|
|
"registrationDate": "2025-06-17",
|
|
"unitName": "山东大学齐鲁医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用输液器",
|
|
"registrationNo": "国械注准2015229379",
|
|
"model": "IS-5.0",
|
|
"batchNo": "A7577034",
|
|
"injuryExpression": "输液部位疼痛",
|
|
"deviceFailure": "滴斗液面波动异常",
|
|
"reviewDate": "2025-06-20",
|
|
"province": "山东省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-000999",
|
|
"occurrenceDate": "2024-01-03",
|
|
"registrationDate": "2024-01-11",
|
|
"unitName": "昆明医科大学第一附属医院",
|
|
"businessUnit": "输液治疗",
|
|
"productName": "一次性使用肠内营养输液器",
|
|
"registrationNo": "国械注准2018843612",
|
|
"model": "EN-SET-2.0",
|
|
"batchNo": "D1024896",
|
|
"injuryExpression": "腹泻",
|
|
"deviceFailure": "营养液温度偏低相关不适",
|
|
"reviewDate": "2024-01-15",
|
|
"province": "云南省",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": true,
|
|
"saeHospitalization": false
|
|
},
|
|
{
|
|
"reportCode": "SIM-2024-001000",
|
|
"occurrenceDate": "2024-07-20",
|
|
"registrationDate": "2024-08-01",
|
|
"unitName": "天津市肿瘤医院",
|
|
"businessUnit": "透析产品",
|
|
"productName": "血液透析管路",
|
|
"registrationNo": "国械注准2017375062",
|
|
"model": "AV-SET-A",
|
|
"batchNo": "A8997713",
|
|
"injuryExpression": "失血相关血红蛋白下降",
|
|
"deviceFailure": "动脉壶液面持续下降",
|
|
"reviewDate": "2024-08-09",
|
|
"province": "天津市",
|
|
"saeDeath": false,
|
|
"saeLifeThreatening": false,
|
|
"saeDisability": false,
|
|
"saeHospitalization": false
|
|
}
|
|
] |