BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE DISPOSABLE BIOPSY SYSTEM

    MDR report key: 4173469 · Received October 10, 2014

    Report

    Report Number
    1018233-2014-00271
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BARD REYNOSA SA DE CV
    Product Code
    KNW
    PMA / PMN Number
    K874585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 PRIOR TO USE ON THE PATIENT THE GUN WOULD FIRE ON ITS OWN AFTER IT WAS COCKED. IN ADDITION, THE GUN MADE AN UNUSUAL SOUND WHEN IT MISFIRED. ANOTHER GUN WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642759 MAXCORE DISPOSABLE BIOPSY SYSTEM KNW BARD REYNOSA SA DE CV NA REYC2389

    Patients

    Seq Age Sex Outcome Treatment
    1