BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEGIANCE

    MDR report key: 286394 · Received July 21, 2000

    Report

    Report Number
    286394
    Event Type
    Other
    Date Received
    July 21, 2000
    Date of Event
    May 24, 2000
    Report Date
    June 14, 2000
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING CAT SCAN GUIDED BONE BIOPSY OF T12 VERTEBRAL BODY TO RULE OUT CANCER. DURING THE PROCEDURE, WHILE REMOVING THE NEEDLE, IT WAS NOTED THAT THE NEEDLE HAD BROKEN AT THE JUNCTION OF THE PROXIMAL THIRD AND DISTAL 2/3. THE REMAINING NEEDLE PART WAS FOUND TO BE IMBEDDED WITHIN THE PEDICLE EXTENDING JUST POSTERIOR TO THE RIGHT 12TH RIB. NEEDLE PIECE LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGIANCE BIOPSY NEEDLE FCG ALLEGIANCE HEALTHCARE * 2719/99

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other