BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM SET

    MDR report key: 8014147 · Received October 29, 2018

    Report

    Report Number
    0008010312-2018-00004
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    July 1, 2018
    Report Date
    August 1, 2018
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    KNW
    UDI-DI
    08033003347881
    PMA / PMN Number
    K013692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE FULFILLING PRESENT REPORT REFERING TO REPORT (B)(4). IN THIS REPORT THE BATCH LOT OF PRODUCTS USED ARE NOT INDICATED. ALTHOUGH WE RECEIVED THE SUPPOSED DEFECTIVE PRODUCT FORM OUR DISTRIBUTOR WHICH ENSURED US TO BE THE PRODUCT OBJECT OF THIS CLAIM. THE KIND OF BREAKAGE WE OBSERVED IS DUE TO A NON-PROPER USE OF PRODUCT, PLEASE LOOK AT THE TECHNICAL REPORT ATTACHED. IN ORDER TO AVOID ANT OTHER PROBLEM WE DECIDED TO BETTER SPECIFY THESE ASPECTS INSIDE IFU SECTION WARNINGS. WE HAVE SENT THIS REVISED IFU TO DISTRIBUTOR ASKING FOR DELIVERY TO THE FINAL USER.

    Description of Event or Problem · 1

    TRAPSYSTEM NEEDLE HANDLE BROKE OFF WHILE BEING INSERTED DURING BONE MARROW BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854466 TRAPSYSTEM SET BONE MARROW BIOPSY SET KNW H.S. HOSPITAL SERVICE S.P.A. 28819 08033003347881

    Patients

    Seq Age Sex Outcome Treatment
    1