BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM SET

    MDR report key: 7968697 · Received October 16, 2018

    Report

    Report Number
    7968697
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 2, 2018
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRAP SYSTEM NEEDLE HANDLE BROKE OFF WHILE BEING INSERTED DURING BONE MARROW BIOPSY. MANUFACTURER RESPONSE FOR BONE MARROW BIOPSY SET TRAP SYSTEM, HS HOSPITAL SERVICE TRAP SYSTEM (PER SITE REPORTER): REPLACED CURRENT STOCK WITH A NEW LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810309 TRAPSYSTEM SET INSTRUMENT, BIOPSY KNW H.S. HOSPITAL SERVICE S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA