BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER

    MDR report key: 19875006 · Received July 30, 2024

    Report

    Report Number
    MW5157819
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE DIFFERENT OCCASIONS THE NEEDLE PLASTIC SAFETY GUARD ON THE BD VACUTAINER POPPED OFF WHEN ATTEMPTING TO ENGAGE. LOTS AFFECTED: 4080265, EXP. 02/28/2029; 4032515, EXP. (1/31/2029); 4109716, (EXP. 3/31/2029). REF: 368607. NO PATIENTS OR STAFF WERE HARMED. REFERENCE REPORTS: MW5157818, MW5157820.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075119 BD VACUTAINER NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON AND COMPANY 4032515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown