BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15572655 · Received October 10, 2022

    Report

    Report Number
    3014704491-2022-00475
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    July 8, 2022
    Report Date
    October 7, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903019489
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER E-MAIL: UNKNOWN. INVESTIGATION SUMMARY: IN RESPONSE TO THE REPORTED EVENT A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111432. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE BROKE IN THE PATIENT'S VEIN, REQUIRING A PARTIAL INCISION OF EPIDERMIS TO REMOVE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "(B)(6) 2022 AT 9:42 IN THE MORNING, THE NURSE USED AN INDWELLING 18G NEEDLE... WHEN THE TUBE IS PLACED, IT IS FOUND THAT 1/3 OF THE NEEDLE WAS BROKEN IN THE BODY WHEN THE NEEDLE IS WITHDRAWN. IMMEDIATELY INFORM THE DOCTOR, TAKE A PARTIAL INCISION OF THE EPIDERMIS, AND REMOVE THE NEEDLE WHEN THE BROKEN NEEDLE TUBE IS FOUND. REPLACE ONE AFTER TAKING IT OUT AND NOTIFY THE SUPPLIER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276702 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1111432 00382903019489

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention