BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 2318557 · Received October 19, 2011

    Report

    Report Number
    1317056-2011-00091
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 21, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECTS OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(4) 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF CONVENIENCE KITS AND THE FAILURE MODE OF "AIR IN SYSTEM." NO ADVERSE TRENDS WERE IDENTIFIED. THE USED FLUID DELIVERY SET WAS RETURNED FOR EVALUATION. NO OTHER KIT COMPONENTS WERE RECEIVED. AS RECEIVED, THE FLUID DELIVERY SET (FDS) TUBING WAS KINKED GREATER THAN 50% OF THE TUBING I.D. NO OTHER DEFECTS WERE NOTED TO THE RETURNED SAMPLE. FUNCTIONAL CHECK: THE FDS WAS AIR LEAK TESTED PER NAVILYST MEDICAL PROCEDURES AT 6PSI. NO DECAY IN PRESSURE WAS OBSERVED TO INDICATE A LEAK IN THE FDS ASSEMBLY. THE CHAMBER OF THE FDS WAS CONNECTED TO A SALINE BAG. THE MALE FITTING OF THE FDS WAS THEN CONNECTED TO A SIDE PORT OF A NAVILYST 3-VALVE MANIFOLD. THE FDS AND MANIFOLD WERE PRIMED BY USING A NAVILYST 12 ML SYRINGE CONNECTED TO THE END FEMALE OF THE MANIFOLD. ONCE THE CONNECTED ASSEMBLY WAS PRIMED, NO AIR BUBBLES WERE VISIBLE. THE MANIFOLD HANDLE WAS TURNED OFF TO THE FDS AND THE FLUID WAS INJECTED OUT OF THE SYRINGE THROUGH THE MANIFOLD. THE SYRINGE WAS FILLED AND EMPTIED 3 TIMES WITH NO BUBBLES NOTED. BASED ON THE ACCEPTABLE RESULTS OF THE VISUAL AND DIMENSIONAL INSPECTIONS, AND THE FUNCTIONAL LEAK TEST EVALUATION OF THE RETURNED FDS, THE CUSTOMER'S COMPLAINT IS UNCONFIRMED FOR AIR IN THE SYSTEM, AND WE CANNOT DEFINITIVELY DETERMINE AN EXACT ROOT CAUSE. THE DIRECTIONS FOR USE SUPPLIED WITH THE CONVENIENCE KITS CONTAINS WARNING: "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM. ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR." "EXAMINE PRODUCT CAREFULLY FOR ENTRAPPED AIR AND FULLY DEBUBBLE PRIOR TO INJECTION TO MINIMIZE THE POTENTIAL FOR EMBOLISM." THE CUSTOMER'S COMPLAINT IS CONFIRMED, HOWEVER, FOR KINKED TUBING. THE MOST PROBABLE ROOT CAUSE IS THAT THE RESPONSIBLE EMPLOYEES FAILED TO PROPERLY VISUALIZE AND/OR FAILED TO PACKAGE THE PRODUCT IN SUCH A WAY AS THE PREVENT KINKING BY LAYING HARD COMPONENTS ON TOP OF SOFT COMPONENTS WHILE PACKAGING. THE EMPLOYEES INVOLVED IN THE PACKAGING OF THE REPORTED KIT LOT HAVE BEEN MADE AWARE OF THIS REPORT AND HAVE BEEN RE-TRAINED ON THE APPLICABLE PACKAGING AND INSPECTION PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(4), DURING PREP FOR A PROCEDURE UTILIZING A NAVILYST CONVENIENCE KIT, THE END USER HOSPITAL OBSERVED THAT: THE TUBING ON THE FLUID DELIVERY SET WAS KINKED AND THE AIR BUBBLES WERE OBSERVED IN THE SYSTEM. THERE WAS NO AFFECT TO THE PT, AS ISSUES WERE NOTED DURING PREP. THE USED FLUID DELIVERY SET HAS BEEN RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL CONVENIENCE KIT LJS NAVILYST MEDICAL NA 4089892

    Patients

    Seq Age Sex Outcome Treatment
    1