BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC 18GA X 1.16IN

    MDR report key: 20463009 · Received October 15, 2024

    Report

    Report Number
    MW5161095
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    October 9, 2024
    Report Date
    October 10, 2024
    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

    THIS MALFUNCTION WAS NOTED BEFORE UTILIZING DEVICE ON A PATIENT. PRIOR TO INSERTION AND UPON VISUAL INSPECTION, THE NEEDLE HAD POKED OUT OF THE SIDE OF THE PLASTIC SHEATH THAT LAID OVER THE NEEDLE. BD INSYTE AUTOGUARD BC 18GA X 1.16IN LOT 4212205, EXP 07/31/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270892 BD INSYTE AUTOGUARD BC 18GA X 1.16IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other