BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD¿ MAGNUM¿ REUSABLE CORE BIOPSY SYSTEM

    MDR report key: 2931736 · Received January 23, 2013

    Report

    Report Number
    2931736
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 23, 2013
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGERY RECEIVED A CALL FROM PATHOLOGY STATING NO TISSUE WAS IN SPECIMEN CONTAINERS 8-12 (WHOLE LEFT SIDE OF TISSUE SAMPLES). THE SCRUB WAS CONSULTED AND SHE STATED SHE SAW TISSUE ON THE NEEDLE WHEN SHE SWISHED IT. SHE STATED AS THE CASE WENT ON THE BIOPSY GUN WAS HARDER TO COCK, BUT SHE KEPT SEEING SPECIMEN. SHE WENT TO PATHOLOGY AND LOOKED AT THE SPECIMENS AND NOTHING WAS IN CONTAINERS BUT BLOOD TINGED SOLUTION. DR WAS NOTIFIED BY PHONE. WE RETRIEVED BIOPSY GUN FROM STERILE PROCESSING AND EXAMINED IT. IT WAS NOTED THAT IT IS BROKEN AND WILL BE SENT OUT FOR REPAIR. THE BIOPSY NEEDLE WAS RETRIEVED AND TISSUE WAS NOTED ACCUMULATED INSIDE HOLLOW SHAFT WHEN BEVEL OF NEEDLE WAS EXPOSED. DR NOTIFIED AND REQUESTED THE TISSUE TO BE LABELED FOR THE 'LEFT' AND SPECIMEN HAND DELIVERED TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32472 BARD¿ MAGNUM¿ REUSABLE CORE BIOPSY SYSTEM INSTRUMENT, BIOPSY, REUSABLE KNW C.R. BARD, INC. * 51GP0184

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CARDIAC DRUGS