BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE DISPOSABLE BIOPSY SYSTEM

    MDR report key: 4102684 · Received August 28, 2014

    Report

    Report Number
    1018233-2014-00227
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 6, 2014
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    KNW
    PMA / PMN Number
    K874585
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUN MISFIRED AND HAD TO BE RESET DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524119 MAXCORE DISPOSABLE BIOPSY SYSTEM KNW BARD REYNOSA S.A. DE C.V. NA REYC2853

    Patients

    Seq Age Sex Outcome Treatment
    1