BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRPSYSTEM SET

    MDR report key: 7237004 · Received February 2, 2018

    Report

    Report Number
    0008010312-2018-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    September 27, 2017
    Report Date
    February 2, 2018
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    KNW
    UDI-DI
    08033003347881
    PMA / PMN Number
    K013692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPOSED DEFECTIVE PRODUCTS WERE NOT RETURNED TO MANUFACTURER SO IT WAS NOT POSSIBLE TO MAKE AN EVALUATION. THE WHOLE BATCH LOT WAS COMPOSED BY (B)(4) PCS, SOLD WORLDWIDE AND NO SUCH CLAIMS HAVE BEEN RECEIVED. DURING THE QUALITY TEST PERFORMED IN PRODUCTION NOTHING WAS WRONG. POSSIBLE EXPLANATION TO THE PROBLEM: THE HANDLE DOES NOT DETACH FROM THE NEEDLE UNTIL ANY METAL DEFORMATION OCCURS. METAL CANNULA USED IS A STANDARD AISI 304 TUBE O.D. 3.0 MM, I.D. 2.3 MM, IF THE MEDICAL DEVICE IS USED INSIDE A VERY HARD BONE IT COULD HAPPEN THAT THE NEEDLE CANNULA CAN STEAKS INSIDE THE BONE, UNDER THESE CONDITIONS FOLLOWING THE IFU, THE DEVICE MUST BE REMOVED FROM THE BONE ROTATING THE HANDLE ONE TURN ON THE RIGHT AND ONE TURN ON THE LEFT IN ORDER TO AVOID ANY METAL CANNULA DEFORMATION AND AFTER THAT THE PLASTIC HANDLE DETACHMENT. THE FACT THAT TWO NEEDLES HAD THE SAME PROBLEM MAYBE CONFIRMS THAT THIS DETACHMENT OCCURRED IN THESE CONDITIONS AND THAT OPERATOR USED THE NEEDLE NOT IN THE RIGHT WAY AS DESCRIBED IN THE IFU. WE ALREADY INFORMED OUR DISTRIBUTOR ABOUT THIS PROBLEM IN DECEMBER 2017. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED IN MW5072812: BONE MARROW BIOPSY SET. 2 SET BROKE DURING THE PROCEDURE CAUSING THE VETERAN TO HAVE TO BE STUCK THREE TIMES IN ORDER TO GET THE BIOPSY. THE SET BROKE AT HANDLE LEAVING A LARGE NEEDLE STUCK IN VETERAN THAT WAS DIFFICULT TO REMOVE. SA 2/2 OTHER-EQUIPMENT ISSUE- MODERATE HARM TO PATIENT. BONE MARROW BIOPSY PROCEDURE TO BE REPEATED BY IR. PATIENT UNDERWENT 3 NEEDLE ATTEMPTS WITH ONE ATTEMPT RESULTING IN HANDLE BREAKING CAUSING NEEDLE TO STAY IN PATIENT WITHOUT HANDLE TO EASILY REMOVE. TWO BONE MARROW BIOPSY KITS BROKE AT POINT OF HANDLE LEAVING A LARGE NEEDLE STUCK IN PATIENT THAT WAS DIFFICULT TO REMOVE. BIOPSY COMPLETED AND ANOTHER BONE MARROW PROCEDURE TO BE REPEATED BY IR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82706 TRPSYSTEM SET BONE MARROW BIOPSY SET KNW H.S. HOSPITAL SERVICE S.P.A. 27869 08033003347881

    Patients

    Seq Age Sex Outcome Treatment
    1