BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 5084118 · Received September 14, 2015

    Report

    Report Number
    1317056-2015-00159
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    July 31, 2015
    Report Date
    August 24, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    OEZ
    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 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)64) 2015 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF CONVENIENCE KITS AND THE FAILURE MODE "AIR BUBBLES." NO ADVERSE TRENDS WERE INDICATED. NO MANUFACTURING NON-CONFORMANCES WERE OBSERVED DURING REVIEW OF THE RETURNED SAMPLES. THE CONNECTION SITE BETWEEN THE RETURNED STOPCOCK AND CONTRAST INJECTION LINE (CIL) APPEARED TO BE FIRMLY ATTACHED, BUT NOT OVER-TIGHTENED. IN ADDITION, A MICROSCOPIC INSPECTION WAS PERFORMED PAYING PARTICULAR ATTENTION TO THE FEMALE LUERS OF THE STOPCOCK AND THE CIL FITTINGS, AND NO CRACKED FITTINGS OR ANY OTHER DAMAGE WAS OBSERVED. ALL FEMALE AND MALE TAPERS, AS WELL AS THE FEMALE THREADS WERE MEASURED AND FOUND TO MEET SPECIFICATION. BOTH DEVICES WERE AIR LEAK TESTED PER NAVILYST MEDICAL PROCEDURES AND PASSED. THE END USER'S COMPLAINT IS UNABLE TO BE CONFIRMED. THERE WERE NO MANUFACTURING RELATED DEFECTS NOTED IN THE RETURNED SAMPLES. THE SAMPLES WERE EVALUATED AND WERE FOUND VISUALLY, DIMENSIONAL AND FUNCTIONALLY ACCEPTABLE. IT IS POSSIBLE THAT THE NED USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE STOPCOCK AND THE CIL AS IT IS STATED IN THE DIRECTIONS FOR USE PROVIDED TO THE CUSTOMER IN THE REPORTED KIT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(4), WHILE UTILIZING AN ANGIOGRAPHIC CONVENIENCE KIT, THE END USER OBSERVED AN AIR LEAK AT THE CONNECTION BETWEEN THE STOPCOCK AND CONTRAST INJECTION LINE AT PRE-TEST, PRIOR TO CLINICAL USE. THERE WAS NO AIR INJECTION OR PATIENT INJURY. THE USED DEVICES HAVE BEEN RETURNED TO NAVILYST MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605368 NAVILYST MEDICAL CONVENIENCE KIT OEZ NAVILYST MEDICAL NA 4851030

    Patients

    Seq Age Sex Outcome Treatment
    1