BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL / VAXCEL

    MDR report key: 2142690 · Received June 21, 2011

    Report

    Report Number
    1317056-2011-00063
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 31, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SERIAL NUMBER ENGRAVED ON THE BACK OF THE PORT (B)(4) IT WAS DETERMINED THAT THE PORT WAS USED IN TWO PACKAGING LOTS - 1232463 AND 1233532 FOR ITEM # M001452150. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE NAVILYST MEDICAL APRIL 2011 COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PORT AND THE FAILURE MODE OF "CATHETER FRACTURED." NO ADVERSE TRENDS WERE IDENTIFIED. AS RECEIVED THE CATHETER WAS STILL ATTACHED TO THE PORT WITH THE LOCKING COLLAR. THE PORT AND CATHETER WERE FLUSHED USING A NON CORING NEEDLE. A HOLE IN THE CATHETER TUBING WAS CONFIRMED DURING FLUSHING AT APPROXIMATELY THE 13-14CM MARKINGS. THE CATHETER WAS OCCLUDED WITH BIO MATTER (DRIED BLOOD) JUST DISTAL TO THE HOLE. AFTER SOAKING IN THE WARM DISINFECTION MIXTURE, MOST OF THE BIO MATTER WAS ABLE TO BE DISCHARGED BY INJECTING THROUGH THE DISTAL END OF THE CATHETER. THE HOLE IN THE CATHETER IS CONSISTENT IN APPEARANCE TO THAT OF A BURST DUE TO OVER-PRESSURIZATION. THE PRESENCE OF WHAT APPEARED TO BE DRIED BLOOD WITHIN THE CATHETER JUST DISTAL TO THE HOLE INDICATES THAT THE CATHETER WAS OCCLUDED, POSSIBLY DUE TO BEING PINCHED AND/OR NOT PROPERLY FLUSHED. MOST LIKELY ROOT CAUSE OF DEFECT IS BURST DUE TO OVER-PRESSURIZATION WHILE INFUSING INTO AN OCCLUDED CATHETER. THE DIRECTIONS FOR USE THAT IS PROVIDED WITH THE DEVICE PROVIDES THE USER WITH INFORMATION AND GUIDANCE FOR VERIFYING PATENCY AND KEEPING THE DEVICE PATENT AFTER IMPLANTATION, AS WELL AS THE CAUTION TO "NEVER FORCIBLY FLUSH AN OCCLUDED LUMEN." INCOMING INSPECTION PROCESS CONTROLS FOR THE CATHETER INCLUDE DIMENSIONAL INSPECTIONS, STATIC BURST TESTING, AND TENSILE TESTING. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, PATIENT HAD VALVED PORT/CATHETER IMPLANTED SINCE (B)(6) 2008. ON (B)(6) 2011, PATIENT FELT DISCOMFORT DURING AN INFUSION. THE PORT WAS REMOVED AND WAS NOTED TO HAVE A SLIT IN THE CATHETER TUBING. THERE WAS NO EXTRAVASATION AND NO OTHER PATIENT COMPLICATIONS. THE PATIENT IS "DOING FINE." THE USED DEVICE WAS RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL / VAXCEL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 1232463

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR