BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30328 11GX6IN BN MARR SNARECOIL NDLE

    MDR report key: 524443 · Received February 13, 2004

    Report

    Report Number
    1282497-2004-00006
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    January 8, 2004
    Report Date
    February 13, 2004
    Manufacturer
    OUTSIDE VENDOR-RANFAC CORPORATION
    Product Code
    KNW
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NEEDLE BROKE OFF IN A PT'S ILIAC CREST. THE OTHER METAL SHEATH DISCONNECTED FROM THE HANDLE. THE INNER SHEATH WITH THE SNARE CAME OUT WITH THE HANDLE. THE HEMATOLOGIST-ONCOLOGIST PERFORMING THE BIOPSY WAS NOT ABLE TO RETRIEVE THE NEEDLE. AN ORTHOPEDIC SURGEON WAS CALLED TO REMOVE THE NEEDLE FROM THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30328 11GX6IN BN MARR SNARECOIL NDLE BONE MARROW BIOPSY NEEDLE KNW OUTSIDE VENDOR-RANFAC CORPORATION * 9103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other