BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 4919625 · Received July 13, 2015

    Report

    Report Number
    1317056-2015-00136
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 05/2015 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF MANIFOLDS, AND THE FAILURE MODE, "AIR BUBBLES NOTED." NO ADVERSE TRENDS WERE IDENTIFIED. RETURNED FOR EVALUATION WAS A THE CONNECTED CONTENTS OF THE CONVENIENCE KIT AS WELL AS THREE BSC CATHETERS (NOT PROVIDED BY NAVILYST MEDICAL). NO DAMAGE OR DEFECTS WERE VISIBLE ON ANY OF THE COMPONENTS. THE MANIFOLD FROM THE KIT WAS AIR LEAK TESTED PER NAVILYST MEDICAL PROCEDURES, AND PASSED. SIMULATED USE TESTING WAS THEN PERFORMED ON THE MANIFOLD AND CATHETER IN AN ATTEMPT TO RE-CREATE THE REPORTED ISSUE: THE ENTIRE SYSTEM (SYRINGE, MANIFOLD AND BSC CATHETER) WAS PRIME AND DE-BUBBLED USING THE 12ML SYRINGE THAT WAS RETURNED WITH THE KIT. FLUID WAS DRAWN INTO THE PRIMED SYSTEM BY ASPIRATING THE SYRINGE PISTON BY HAND. NO AIR WAS OBSERVED DURING 5/5 ASPIRATIONS. THE SAME TESTING WAS PERFORMED ON THE TWO REMAINING BSC CATHETERS. FLUID LEAKAGE AT THE LOCATION OF THE MANIFOLD ROTATING ADAPTOR WAS ALSO NOT OBSERVED WHEN THE CATHETER WAS CLAMPED OFF AND AN INJECTION ATTEMPTED WITH THE SYRINGE. THE FEMALE THREADS OF THE MANIFOLD PORTS AS WELL AS THE SYRINGE MALE TAPER WERE MEASURED AND FOUND TO MEET SPECIFICATION. THE SYRINGE WAS ALSO LEAK TESTED, AND PASSED. MULTIPLE ATTEMPTS WERE MADE TO DUPLICATE THE REPORTED FAILURE MODEL AND IN ALL CASES NO BUBBLES WERE NOTE D IN THE MANIFOLD SYSTEM. COMPLAINT CANNOT BE CONFIRMED AS THE ASSEMBLY MEETS SPECIFICATION AND FUNCTIONED AS INTENDED. DHR SEARCH REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE MANIFOLD AND THE DEVICE TO WHICH THEY WERE CONNECTING (BSC 6F CATHETER) WERE NOT "FINGER TIGHTENED" PRIOR TO USE AS IT IS STATED IN THE DIRECTIONS FOR USE (DFU) PROVIDED TO THE CUSTOMER IN THE REPORTED KIT. THE DFU CONTAINS THE FOLLOWING STATEMENTS, "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." (B)(4).

    Description of Event or Problem · 1

    AS REPORTED: AIR BUBBLES ARE BEING SEEN ENTERING THE SYSTEM AT THE LOCATION WHERE THE CATHETER (NOT PROVIDED BY NAVILYST MEDICAL) IS ATTACHED TO THE MALE ROTATING ADAPTOR ON THE MANIFOLD WHICH IS PROVIDED IN THE CONVENIENCE KIT. SAMPLES OF THE MANIFOLD AND CATHETER HAVE BEEN RETURNED FOR EVALUATION. THERE HAS BEEN NO AIR INJECTION OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451862 NAVILYST MEDICAL CONVENIENCE KIT OEZ NAVILYST MEDICAL NA 4865010

    Patients

    Seq Age Sex Outcome Treatment
    1