BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER PLUS 0.9MM 20 GAUGE X 19MM 3/4"

    MDR report key: 3001711 · Received March 8, 2013

    Report

    Report Number
    MW5029329
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SMITHS MEDICAL ASSO, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE DEACCESSING A PTS' INFUSIPORT, THE SAFETY MECHANISM ON THE HUBER NEEDLE FAILED, LEAVING THE NEEDLE BARE INSTEAD OF INSIDE THE PROTECTIVE SHEATH AS IT SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100033 GRIPPER PLUS 0.9MM 20 GAUGE X 19MM 3/4" NON-CORING SAFETY NEEDLE FMI SMITHS MEDICAL ASSO, INC. 21-2965-24 32 X 966

    Patients

    Seq Age Sex Outcome Treatment
    1