BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 4781797 · Received April 16, 2015

    Report

    Report Number
    2020394-2015-00508
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    March 12, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE INVESTIGATION IS INCONCLUSIVE, AS THE DEVICE WAS NOT RETURNED FOR EVAL. 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 DURING MULTIPLE ULTRASOUND GUIDED BREAST BIOPSY PROCEDURES, PRIOR TO OBTAINING ANY TISSUE SAMPLES, THE DEVICE WAS NOT ABLE TO LOCK INTO THE PRIMED POSITION ON THE SECOND ROTATION. A RATTLING NOISE WAS ALSO REPORTED COMING FROM INSIDE THE DEVICE. A COAXIAL WAS USED DURING EACH OF THE PROCEDURES. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256287 MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. REYJ1221

    Patients

    Seq Age Sex Outcome Treatment
    1