BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON

    MDR report key: 9574633 · Received January 10, 2020

    Report

    Report Number
    9574633
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    November 19, 2019
    Report Date
    November 19, 2019
    Manufacturer
    MCKESSON MEDICAL-SURGICAL INC.
    Product Code
    FMI
    UDI-DI
    10612479201382
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WENT TO USE AN UNOPENED MCKESSON BRAND PREVENT M SAFETY NEEDLE 25GX 1", LOT # 922693, EXP 6/30/24 AND FOUND THAT THE HUB OF THE NEEDLE HAD A GREEN SUBSTANCE ON IT AND IT DID NOT APPEAR STERILE OR APPROPRIATE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40183 MCKESSON NEEDLE, HYPODERMIC, SINGLE LUMEN FMI MCKESSON MEDICAL-SURGICAL INC. 26559 922693 10612479201382

    Patients

    Seq Age Sex Outcome Treatment
    1