BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA

    MDR report key: 983889 · Received December 27, 2007

    Report

    Report Number
    983889
    Event Type
    Malfunction
    Date Received
    December 27, 2007
    Date of Event
    March 22, 2007
    Report Date
    December 27, 2007
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    RN HAD COMPLETED PHERESIS ON CUSTOMER AND WAS WITHDRAWING THE NEEDLE FROM THE CUSTOMER'S ARM. AS SHE WAS PULLING THE NEEDLE OUT OF THE ARM, THE NEEDLE SLID SIDEWAYS AND INTO HER LEFT THUMB INSTEAD OF INTO THE SAFETY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA KIT, TUBING, BLOOD COLLECTION GKT GAMBRO BCT, INC. * 09L2229

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR