BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCORE DISPOSABLE BIOPSY SYSTEM

    MDR report key: 4173471 · Received October 10, 2014

    Report

    Report Number
    1018233-2014-00270
    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

    RECEIVED 1 USED MAX-CORE BIOPSY INSTRUMENT WITH THE ORIGINAL UNIT PACKAGING. BASED ON THE COMPLAINT EVALUATION, THE COMPLAINT IS UNCONFIRMED AS "MISFIRE" WAS DUPLICATED WITH THE RETURNED SAMPLE. NO VISIBLE DAMAGES WERE OBSERVED THAT COULD CAUSE A FUNCTIONAL FAILURE. VISUAL INSPECTION WAS PERFORMED TO THE COMPLAINT RETURNED SAMPLE: IT WAS NOTED THAT THE NEEDLE AND PLASTIC GUARD SHOWS RESIDUES OF BLOOD. A FUNCTIONAL TEST WAS PERFORMED; COMPLAINT SAMPLE WAS TESTED 30 TIMES, 15 TIMES WITH EACH TRIGGER. NONE OF THE TRIALS FAILED TO COCK / FIRE ON THE COMPLAINT SAMPLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    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
    642626 MAXCORE DISPOSABLE BIOPSY SYSTEM KNW BARD REYNOSA SA DE CV MA REYC2853

    Patients

    Seq Age Sex Outcome Treatment
    1