BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE

    MDR report key: 2425102 · Received January 17, 2012

    Report

    Report Number
    9681442-2012-00007
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 20, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    DWO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE NEEDLE INTO L 5/S 1. THE HANDGRIP WAS ATTACHED TO THE CANNULA AND THE DEVICE WAS ADVANCED INTO THE PT. AFTER THE CANNULA REACHED THE LESION, THE SYRINGE WAS ATTACHED TO THE CANNULA AND A TISSUE SAMPLE WAS COLLECTED. AFTER THAT, THE PHYSICIAN ATTEMPTED TO PULL OUT THE CANNULA. THE CONNECTION PART OF THE HUB AND THE PROXIMAL PART OF THE NEEDLE WAS BROKEN. AT THAT TIME, THE REST OF THE NEEDLE REMAINED IN THE PT, BUT COULD BE REMOVED WITH "NIPPERS." THE NEEDLE BROKE INTO TWO PIECES. BOTH PIECES WERE REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE DWO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVE1572

    Patients

    Seq Age Sex Outcome Treatment
    1