BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER

    MDR report key: 18570418 · Received January 24, 2024

    Report

    Report Number
    18570418
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    November 22, 2023
    Report Date
    November 29, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SAFETY SHIELD COVERING THE NEEDLE CAME UNHINGED. NO INJURY TO TEAM MEMBER OR PATIENT. THE SAFETY SHIELD BROKE OFF WHILE ENGAGING THE PLASTIC PIECE. THE LOT OF NEEDLES WAS PULLED FROM USE (#3223399).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953963 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE PRE-ATTACHED HOLDER NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON, DICKINSON AND COMPANY 368650 3223399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown