BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 4781755 · Received April 16, 2015

    Report

    Report Number
    2020394-2015-00240
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE INVESTIGATION IS INCONCLUSIVE, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE SUPPLIER RELATED DUE TO OVER-PROCESSED RESIN. THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINT/ REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR BIOPSY PROCEDURE, THE DEVICES FAILED TO PRIME ON THE SECOND ROTATION OF THE KNOB AND A RATTLING NOISE WAS HEARD AS THOUGH SOMETHING WAS BROKEN. THE DEVICES WERE EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256282 MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT KNW KNW BARD PERIPHERAL VASCULAR, INC. REY12147

    Patients

    Seq Age Sex Outcome Treatment
    1