BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAUER CORDIAL BIOPSY SYSTEM

    MDR report key: 50343 · Received November 20, 1996

    Report

    Report Number
    MW1010281
    Event Type
    Malfunction
    Date Received
    November 20, 1996
    Date of Event
    October 15, 1996
    Report Date
    October 25, 1996
    Manufacturer
    BAUER MEDICAL, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRIGGER MECHANISM OF BARREL OF BIOPSY NEEDLE CAME LOOSE FROM THE HANDLE DURING USER IN RADIOLOGY. NO INJURY TO PT. JUST DEFECTIVE BIOPSY NEEDLE. WILL RETURN TO MFR 10/28/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAUER CORDIAL BIOPSY SYSTEM BIOPSY NEEDLE (TEMNO) KNW BAUER MEDICAL, INC. * 8/96A96

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other