BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM

    MDR report key: 5856166 · Received August 9, 2016

    Report

    Report Number
    5856166
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    July 20, 2016
    Report Date
    August 5, 2016
    Manufacturer
    HS HOSPITAL SERVICE S.P.A.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A BONE MARROW BIOPSY PROCEDURE THE CORE NEEDLE BENT AT APPROXIMATELY A 45 DEGREE ANGLE. THE PHYSICIAN WAS ABLE TO GET AN ACCEPTABLE SAMPLE, SO THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512015 TRAPSYSTEM INSTRUMENT, BIOPSY KNW HS HOSPITAL SERVICE S.P.A. 25539

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR