BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST

    MDR report key: 2031508 · Received March 21, 2011

    Report

    Report Number
    1317056-2011-00027
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 SPECIFICATIONS. THE (B)(6) 2011, (B)(4) 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 RETURNED MANIFOLD WAS VISUALLY EXAMINED AND FOUND TO HAVE A LENGTH-WISE CRACK OF THE PROXIMAL FEMALE PORT. NO OTHER DAMAGE WAS NOTED. DUE TO THE DAMAGE, AN ACCURATE DIMENSIONAL MEASUREMENT OF THE PORT COULD NOT BE TAKEN, HOWEVER, THE FOUR FEMALE SIDE PORTS WERE FOUND TO BE WITHIN DIMENSIONAL SPECIFICATION. THIS FAILURE DOES NOT APPEAR TO BE A MFG RELATED DEFECT. BASED ON THE VISUAL EXAMINATION OF THE RETURNED SAMPLE, THE MOST PROBABLE ROOT CAUSE IS THAT THE FEMALE LUER OF THE MANIFOLD AND THE MATING MALE LUER OF THE SYRINGE WERE OVER TIGHTENED AND CONTRIBUTED TO THE CRACKED MANIFOLD PORT. THE DIRECTIONS FOR USE PACKAGED WITH THE KIT INCLUDES THE FOLLOWING STATEMENT: "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM THAT COULD RESULT IN EMBOLISM AND IN RARE INSTANCES OF DEATH. ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR THAT COULD RESULT IN EMBOLISM AND OR EXPOSURE TO BIOHAZARDS. EXAMINE PRODUCT CAREFULLY FOR ENTRAPPED AIR AND FULLY DEBUBBLE PRIOR TO INJECTION TO MINIMIZE THE POTENTIAL FOR EMBOLISM AND IN RARE INSTANCES DEATH." MFG PROCESS CONTROLS FOR THE MANIFOLDS INCLUDE IN-PROCESS VISUAL INSPECTIONS (VERIFICATION THAT THE BODY IS FREE OF MOLDING DEFECTS, DAMAGE AND/OR CRACKS), LEAK TESTING, AND DIMENSIONAL VERIFICATION OF FEMALE TAPERS AND THREADS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, DURING A CARDIAC CATHETERIZATION PROCEDURE, THE PHYSICIAN ASPIRATED AIR WITH AN ANGIOGRAPHIC SYRINGE CONNECTED TO A 4-VALVE MANIFOLD (BOTH ITEMS FROM NAVILYST CONVENIENCE KIT). AIR WAS NOT INJECTED AND THERE WAS NO PT INJURY. THE USED MANIFOLD WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST CONVENIENCE KIT DQX NAVILYST MEDICAL NA 4020784

    Patients

    Seq Age Sex Outcome Treatment
    1