BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPSYSTEM 11GX100MM

    MDR report key: 6958055 · Received October 18, 2017

    Report

    Report Number
    MW5072812
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 16, 2017
    Manufacturer
    H.S. HOSPITAL SERVICE SPA
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BONE MARROW BIOPSY SET - 2 SETS BROKE DURING THE PROCEDURE CAUSING THE VETERAN TO HAVE TO BE STUCK THREE TIMES IN ORDER TO GET BIOPSY. THE SET BROKE AT HANDLE LEAVING A LARGE NEEDLE STUCK IN VETERAN THAT WAS DIFFICULT TO REMOVE. SAC 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 DURING PROCEDURE; KIT BROKE AT POINT OF HANDLE LEAVING A LARGE NEEDLE STUCK IN PATIENT THAT WAS DIFFICULT TO REMOVE. BIOPSY COMPLETED AND ANOTHER BONE MARROW BIOPSY PROCEDURE TO BE REPEATED BY IR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739240 TRAPSYSTEM 11GX100MM BONE MARROW BIOPSY SET KNW H.S. HOSPITAL SERVICE SPA 27869
    739241 TRAPSYSTEM 11GX100MM BONE MARROW BIOPSY SET KNW H.S. HOSPITAL SERVICE SPA 27869

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR