BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL / NAMIC

    MDR report key: 1925949 · Received November 24, 2010

    Report

    Report Number
    1317056-2010-00078
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K852140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPECS. THE NAVILYST MEDICAL (B)(4) 2010 COMPLAINT REPORT WAS REVIEWED FOR THE FLUID DELIVERY SET (FDS) PRODUCT FAMILY AND THE FAILURE MODE OF "AIR BUBBLES." NO ADVERSE TRENDS WERE NOTED. THE DEVICE FROM THE REPORTED INCIDENT WAS NOT RETURNED, HOWEVER, AN UNUSED DEVICE FROM THE REPORTED PRODUCT LOT WAS RECEIVED FOR EVAL. THE CHAMBER OF THE FLUID DELIVERY SET WAS CONNECTED TO A SALINE BAG. THE MALE FITTING OF THE DEVICE WAS CONNECTED TO A DIE PORT OF NAVILYST 3 VALVE MANIFOLD. THE FDS AND MANIFOLD WERE PRIMED WITH A 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 VISIBLE UNDER THE FILTER OF THE CHAMBER, OR ANYWHERE WITHIN THE PRIMED SYSTEM. THE REPORTED COMPLAINT OF AIR BUBBLES CANNOT BE CONFIRMED. THE FDS IS A PURCHASED DEVICE FOR NAVILYST MEDICAL INCOMING INSPECTION INCLUDES A STATISTICAL SAMPLING OF DEVICES TO VERIFY ACCEPTABLE BONDING, AS WELL AS PERFORMING A LEAK TEST AND A PULL TEST. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, DURING A NEURO INTERVENTION PROCEDURE, AIR BUBBLES WERE NOTICED BELOW THE FILTER IN THE CHAMBER OF THE FLUID DELIVERY SET. NO AIR WAS INJECTED INTO THE PT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE PT CONDITION WAS DESCRIBED AS "UNAFFECTED." AN UNUSED DEVICE FROM THE SAME LOT WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL / NAMIC SET, ADMINISTRATION, INTRAVASCULAR FPA NAVILYST MEDICAL NA 4067845

    Patients

    Seq Age Sex Outcome Treatment
    1