BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX IC COMPLETE CARE FOLEY TRAY

    MDR report key: 2695997 · Received August 10, 2012

    Report

    Report Number
    1018233-2012-00929
    Event Type
    Malfunction
    Date Received
    August 10, 2012
    Report Date
    March 1, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    MJC
    PMA / PMN Number
    K910318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A CORRECTIVE ACTION TO AN OBSERVATION ON FDA FROM 483 DATED (B)(4) 2012 FOR BARD MEDICAL DIVISION. RECEIVED TWO FOLEY TRAYS WITH ITS ORIGINAL PACKAGE OPENED. ANOTHER FDA 3500A FORM (1018233-2012-00928) WILL BE PROVIDED FOR THE SECOND PRODUCT RECEIVED. THE SAMPLES WERE INSPECTED FOR INCOMPLETE SEAL AND IT WAS NOTICED THE SUPPLIER SEAL OF BOTH PACKAGES WAS PARTIALLY OPENED. THE OPENINGS WERE LOCATED IN THE MIDDLE (CENTER) OF THE BOTTOM SEAL OF THE HEADER STRIP BAG. IN BOTH SAMPLES, IT WAS OBSERVED THE OVAL VENT HOLE IN THE HEADER STRIP FILM LAYER WAS MISSING. THE SPECIFICATIONS REQUIRE A CUT OPENING (OVAL). THE SEAL TRANSFER WAS REVIEWED AND THERE WERE NO PROBLEMS OF MISSING OR WEAK SEAL. THE SEAL WAS OPENED WHEN THE SAMPLE WAS STERILIZED DUE TO THE MISSING OVAL VENT HOLE, THEREFORE, NOT ALLOWING THE BAG TO "BREATHE" DURING THE STERILIZATION PROCESS. NO OTHER DAMAGES OR PROBLEMS WERE OBSERVED. THE COMPLAINT IS CONFIRMED AND RELATED TO THE MANUFACTURING PROCESS OF THE SUPPLIER. THE SUPPLIER VENT HOLE PUNCHING MACHINE HAD A DISCONNECTION IN THE AIR LINE THAT SUPPLIES THE PNEUMATIC VENT HOLE PUNCH. THE PACKAGE LABELING STATES "STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR THE HAND SANITIZER AND CASTILE SOAP TOWELETTES WHICH ARE NOT TERMINALLY STERILIZED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEAL WAS INCOMPLETE ON THE STERILE PACKAGE. FOUND PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX IC COMPLETE CARE FOLEY TRAY MJC PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGVJ1105

    Patients

    Seq Age Sex Outcome Treatment
    1