BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 4781803 · Received April 16, 2015

    Report

    Report Number
    2020394-2015-00451
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    March 26, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW WAS CONDUCTED AND IT WAS DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUIRED. THE LOT MET ALL RELEASE CRITERIA. THE DEVICE WAS RETURNED HALF PRIMED, WITH THE CANNULA RETRACTED, EXPOSING THE SAMPLE NOTCH. LOOSE PARTICLES COULD BE HEART WITHIN THE DEVICE. THERE WERE NO VISUAL ANOMALIES NOTED ON THE SAMPLE. THE SAMPLE WAS FUNCTIONALLY TESTED BY TWISTING THE ROTATIONAL KNOB ONCE AND THE STYLET RETRACTED AND LOCKED INTO PLACE AS EXPECTED. HOWEVER, THE CANNULA RELEASED BACK TO THE INITIAL POSITION. AS A RESULT, THE STYLET WAS RETRACTED INTO THE CANNULA AND COULD NOT BE SEEN. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE DEVICE COULD NOT BE FULLY PRIMED. THE SAMPLE WAS DISASSEMBLED AND THE INTERNAL COMPONENTS WERE EXAMINED. THE CANNULA HUB WAS FOUND TO BE BROKEN. THE INVESTIGATION IN CONFIRMED FOR A BREAK, AS THE CANNULA HUB WAS FOUND TO BE BROKEN. THE INVESTIGATION IS INCONCLUSIVE FOR FAILURE TO FIRE, AS THE DEVICE COULD NOT BE FUNCTIONALLY TESTED DUE TO THE BROKEN COMPONENTS. THE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE SUPPLIER RELATED DUE TO OVER-PROCESSED RESIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE FAILED TO FIRE DURING THE US GUIDED BREAST BIOPSY AFTER BEING FULLY PRIMED. A COAXIAL WAS USED DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256279 MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REYI2147

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR