BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSTYLE AUTOGUARD BC 22G

    MDR report key: 21978613 · Received May 7, 2025

    Report

    Report Number
    MW5170067
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 1, 2025
    Manufacturer
    BD/BECTON DICKINSON
    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

    BD INSYTE AUTOGUARD 22G IV CATHETER DID NOT GIVE BLOOD REFILL IN THE CATHETER AFTER NEEDLE RETRACTED AS IT SHOULD. LOT: 5021175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795565 BD INSTYLE AUTOGUARD BC 22G CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD/BECTON DICKINSON 5021175

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other