BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAMIC/VA

    MDR report key: 1050132 · Received May 14, 2008

    Report

    Report Number
    3005099803-2008-00459
    Event Type
    Injury
    Date Received
    May 14, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 18, 2008
    Manufacturer
    NAMIC/VA
    Product Code
    LJT
    PMA / PMN Number
    k032008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN REC'D BY THIS MFR, BUT A PHYSICAL EVAL HAS NOT YET BEEN COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPEC. THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED; NO ANOMALIES WERE NOTED TO BE RELATED TO THE REPORTED DEFECT. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE FEMALE PT WAS ADMITTED TO THE FACILITY FOR SAME DAY SURGERY IN 2008. THE PT WAS SCHEDULED TO UNDERGO THE EXPLANT OF A VAXCEL IMPLANTABLE PORT, DUE TO A MALFUNCTION OF THE PORT THAT HAD BEEN IMPLANTED IN THE PT IN 2006. UPON INSPECTION OF THE RESERVOIR CATHETER JUNCTION, THE CATHETER WAS FOUND TO BE COMPLETELY DETACHED FROM THE RESERVOIR. AFTER REMOVAL OF THE RESERVOIR, THE PT WAS REFERRED TO THE INTERVENTIONAL RADIOLOGY DEPT FOR TRANSVENOUS REMOVAL OF THE CATHETER. AT ABOUT 4 DAYS LATER, THE PT RETURNED TO THE FACILITY AND THE CLINICIANS SUCCESSFULLY RETRIEVED THE BROKEN AND MIGRATED CATHETER FROM THE PT'S INNOMIATE VEIN AND VENA CAVA. A REPLACEMENT CATHETER WAS NOT IMPLANTED IN THE PT. THE COMPLAINANT REPORTED THAT THERE DOES NOT APPEAR TO BE ANY ADVERSE EFFECTS ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC/VA IMPLANTABLE PORT LJT NAMIC/VA M001452150 1083556

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention