[ { "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, "saeLifeThreatening": false, "saeDisability": false, "saeHospitalization": false }, { "reportCode": "SIM-2024-000002", "occurrenceDate": "2025-10-12", "registrationDate": "2025-10-16", "unitName": "浙江大学医学院附属第二医院", "businessUnit": "透析产品", "productName": "血液透析器", "registrationNo": "国械注准205476036", "model": "HD-180", "batchNo": "G9057869", "injuryExpression": "透析中低血压", "deviceFailure": "跨膜压波动偏大", "reviewDate": "2025-10-22", "province": "浙江省", "saeDeath": false, "saeLifeThreatening": false, "saeDisability": false, "saeHospitalization": false }, { "reportCode": "SIM-2024-000003", "occurrenceDate": "2024-08-10", "registrationDate": "2024-08-22", "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", "batchNo": "G5982691", "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, "saeHospitalization": false }, { "reportCode": "SIM-2024-000004", "occurrenceDate": "2025-11-27", "registrationDate": "2025-12-02", "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", "batchNo": "C7618651", "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", "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", "batchNo": "D5605540", "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", "registrationDate": "2024-12-31", "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 }, { "reportCode": "SIM-2024-000009", "occurrenceDate": "2025-01-11", "registrationDate": "2025-01-16", "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", "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", "occurrenceDate": "2024-02-19", "registrationDate": "2024-02-23", "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": 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"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 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"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": 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"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, 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"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 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"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, 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"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 } ]