BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD HEYMAR UROLOGIST TRAY

    MDR report key: 2934901 · Received January 4, 2013

    Report

    Report Number
    1018233-2013-00012
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 11, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KOE
    PMA / PMN Number
    PRE AM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND THE REPORTED ISSUE IS CONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED A HOLE (MEASURED 0.5470") LOCATED IN LEFT SIDE OF THE TYVEK LID, OVER THE "UROLOGIST'S" PRINTING. FURTHER EXAMINATION NOTED THE HOLE IN THE LEFT SIDE OF THE TYVEK LID APPEARS TO HAD BEEN CAUSED BY THE INTERNAL TOP TRAY. DURING EXAMINATION WHEN THE TRAY WAS OPENED, IT WAS NOTED THAT THE INTERNAL TOP TRAY HAD POSITIONED IN THE BOTTOM TRAY FROM BEING IN ITS ORIGINAL POSITION IN THE MIDDLE. THE DAMAGES OBSERVED ON THE SIDE AND IN THE BOTTOM OF THE TRAY POSSIBLY INDICATIVE AS IF THE TRAY HAD BEEN BEATEN. THERE WERE NO DISCREPANCIES FOUND WITHIN THE SEALING PROCESS THAT COULD HAVE CAUSED THE HOLE IN THE TRAY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO REJECTS WERE FOUND. THERE WERE NO MFG DISCREPANCIES FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND TO BE ADEQUATE BECAUSE IT CLEARLY SPECIFIES THAT THE PRODUCT IS STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRAY HAD A HOLE IN IT COMPROMISING THE STERILITY OF THE PRODUCT. HOLE WAS FOUND PRIOR TO OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5592 BARD HEYMAR UROLOGIST TRAY KOE PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGWJ3361

    Patients

    Seq Age Sex Outcome Treatment
    1