BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM

    MDR report key: 2282571 · Received September 16, 2011

    Report

    Report Number
    2282571
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 16, 2011
    Manufacturer
    HS HOSPITAL SERVICE S.P.A.
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A BONE MARROW ASPIRATE AND BIOPSY PROCEDURE, WHEN THE ASPIRATE NEEDLE WAS BEING REMOVED, THE GREEN HANDLE BECAME LOOSE AND WAS NO LONGER FIRMLY ATTACHED TO THE NEEDLE. TWO HEMOSTATS WERE USED TO SAFELY REMOVE THE ASPIRATE NEEDLE WITHOUT ANY HARM TO THE PT. ANOTHER SITE AND NEEDLE SET WERE USED TO OBTAIN THE CORE BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPSYSTEM BONE MARROW BIOPSY SET FCG HS HOSPITAL SERVICE S.P.A. TRAPJ 1110 6096

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR