BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BC 20 GAX1.00IN

    MDR report key: 22411306 · Received July 7, 2025

    Report

    Report Number
    MW5172232
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 26, 2025
    Report Date
    June 27, 2025
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPENED AN IV PACKAGE TO START AN IV AND NOTICED A DEFECT ON THE END OF PLASTIC CATHETER THAT LOOKED LIKE FUZZ OR FRAYED PLASTIC. IT WAS ATTACHED TO PLASTIC CATHETER. BD INSYTE AUTOGUARD BC 20 GAX1.00IN LOT NUMBER 5077173, EXP DATE: 2028-02-29, MFR DATE 2025-03-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768107 INSYTE AUTOGUARD BC 20 GAX1.00IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON AND COMPANY 5077173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other