BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM SET

    MDR report key: 7352372 · Received March 20, 2018

    Report

    Report Number
    0008010312-2018-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    January 31, 2018
    Report Date
    March 20, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLES RECEIVED HAD METAL PARTS BENT AND PLASTIC HANDLE DETACHED. METAL PART OF THE NEEDLE ARE IN AISI 304, UNIVERSALLY RECOGNIZED METAL USED FOR MEDICAL DEVICE. PLASTIC PART DETACHED WAS THE MANDREL HANDLE, WE CHECKED THAT GLUE WAS PRESENT SO THE HANDLE WAS CORRECTLY ASSEMBLED. WE ATTACH A TECHNICAL REPORT EXPLAINING HOW THESE PROBLEMS CAN OCCUR IF DURING A BIOPSY "IFU" ARE NOT STRICTLY FOLLOWED. WE SELL MORE THAN 60.000 PCS DURING AN YEAR AND WORLD WIDE. WE ARE RECEIVING THESE KIND OF CLAIMS ONLY FROM THIS HOSPITAL. WE HAVE ACTIVATED OUR DISTRIBUTOR IN ORDER TO TRAIN OPERATORS TO THE CORRECT USAGE OF THE PRODUCT. WE ALSO HAVE RECEIVED BACK SOME NEEDLES SUPPOSED TO HAVE FAILED THE ASPIRATION OF BLOOD DURING THE PROCEDURE. WE TESTED THE PRODUCT ASPIRATION AND WE HAVE NOT FOUND ANY PROBLEM. PLEASE ALSO REFER TO THE TECHNICAL REPORT ATTACHED. PRESENT TECHNICAL REPORT HAS BEEN SENT TO DISTRIBUTOR AND THEN TO FINAL OPERATORS. [TECHNICAL REPORT (B)(4).PDF].

    Description of Event or Problem · 1

    DURING THE BONE MARROW PROCEDURE THE JAMSHIDI NEEDLE BENT OR BROKE AND WAS UNABLE TO BE USED (3 NEEDLES USED IN (B)(6) 2018).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196342 TRAPSYSTEM SET BONE MARROW BIOPSY SET KNW H.S. HOSPITAL SERVICE S.P.A. 28929 08033003347881

    Patients

    Seq Age Sex Outcome Treatment
    1