BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 20818309 · Received December 2, 2024

    Report

    Report Number
    20818309
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    October 12, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PACKAGING OPENED ON BD 23 GAUGE BUTTERFLY DEVICE, UPON REMOVING THE SMALL PLASTIC SHEATH FROM THE NEEDLE, THE NEEDLE BENT. THE GENTLE FORCE IT TAKES TO REMOVE THIS SHEATH SHOULD NOT CAUSE THIS TO HAPPEN. LOT #4162537.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337867 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON, DICKINSON AND COMPANY 367364 4162537

    Patients

    Seq Age Sex Outcome Treatment
    1 123 YR Unknown