BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC/VA

    MDR report key: 1046717 · Received May 16, 2008

    Report

    Report Number
    3005099803-2008-00493
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    April 10, 2008
    Manufacturer
    NAMIC/VA
    Product Code
    LJT
    PMA / PMN Number
    K982888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, BUT A PHYSICAL EVALUATION HAS NOT YET BEEN PERFORMED. AT THIS TIME WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. THE DEVICE HISTORY RECORDS REVIEW FOR THIS LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR LOT NUMBER 1021621.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT IN 2006, A THERAPEUTIC IMPLANT OF THE VAXCEL MICROPORT WAS PERFORMED ON A FEMALE PATIENT. IT WAS REPORTED THAT ALL WENT FINE WITH THE DEVICE UNTIL 2008. AT THAT TIME, THE CLINICIANS WERE UNABLE TO OBTAIN A BLOOD RETURN AND THE DEVICE WAS DIFFICULT TO FLUSH. THE PATIENT ALSO REPORTED THAT AT THAT TIME SHE FELT COLDNESS AT THE SITE LOCATED IN HER LEFT UPPER INNER ARM. ON THE FOLLOWING MONTH, THE PATIENT RETURNED TO THE FACILITY AND THE DEVICE WAS SUCCESSFULLY REMOVED. A REPLACEMENT DEVICE WAS NOT IMPLANTED IN THE PATIENT AT THAT TIME. THE COMPLAINANT INDICATED THAT THE PATIENT'S CONDITION WAS "FINE". THE DEVICE WAS RETURNED AND ON THE NEXT MONTH, A PRELIMINARY INSPECTION OF THE DEVICE WAS PERFORMED; AT THAT TIME A HOLE WAS FOUND IN THE DEVICE CATHETER. IN ADDITION, IT HAS ALSO BEEN DETERMINED THAT THE BATCH NUMBER OF THIS DEVICE EXPIRED ON FEBRUARY 28, 2007, MORE THAN A YEAR AFTER IT WAS EXPLANTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC/VA PORT LJT NAMIC/VA M001453180 1021621

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR