BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM NEEDLE AND TRAP

    MDR report key: 3033394 · Received March 18, 2013

    Report

    Report Number
    3033394
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    HS MEDICAL INC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FACILITY HAS USED THE SAME NEEDLES FOR MANY YEARS. STAFF NOTED THAT THE CANNULA TOP HAD CHANGED COLORS AT WHICH TIME THEY NOTED THE SPECIMEN WAS "NOT BEING LOCKED INTO THE NEEDLE" AND THEY WERE LOSING THE SPECIMENS, REQUIRING ANOTHER STICK FOR THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BONE MARROW BIOPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112431 TRAPSYSTEM NEEDLE AND TRAP INSTRUMENT, BIOPSY KNW HS MEDICAL INC * W1301123

    Patients

    Seq Age Sex Outcome Treatment
    1 * THIS INVOLVED DIFFERENT PATIENTS