BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 2844949 · Received October 24, 2012

    Report

    Report Number
    2020394-2012-00238
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Report Date
    August 28, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER FOR THIS FAILURE MODE. THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, A DRY TEST WAS PERFORMED INTO THE AIR AND THE NEEDLE DISCONNECTED FROM THE BIOPSY INSTRUMENT, LANDING SOME DISTANCE AWAY FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REWD1260

    Patients

    Seq Age Sex Outcome Treatment
    1