BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC

    MDR report key: 24618301 · Received March 16, 2026

    Report

    Report Number
    MW5185327
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 3, 2026
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    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

    IV NEEDLE SLOW TO RETRACT, ONLY FULLY RETRACTED ONCE REMOVED AFTER INSERTION. LOT #6020809 BD INSYTE AUTOGUARD BC. THE NEEDLE NOT RETRACTING POSES A SAFETY RISK TO THE USER. NO PATIENT HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675160 BD INSYTE AUTOGUARD BC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6020809

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other