BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 4568975 · Received February 24, 2015

    Report

    Report Number
    1317056-2015-00057
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DXT
    PMA / PMN Number
    K822100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 (B)(6) 2014 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF CONTRAST INJECTION LINES AND THE FAILURE MODE "AIR BUBBLES." NO ADVERSE TRENDS WERE INDICATED. INITIAL INSPECTION OF THE RETURNED (UNUSED) CONTRAST INJECTION LINE (CIL) SHOWED NO DAMAGE OR DEFECTS. MICROSCOPIC INSPECTION OF THE FEMALE LEUR & MALE ROTATING ADAPTOR DID NOT REVEAL ANY CRACKS. THE FEMALE AND MALE TAPERS, AS WELL AS THE FEMALE THREADS WERE MEASURED AND ALL WERE FOUND TO BE WITHIN DIMENSIONAL SPECIFICATION. THE DEVICE WAS THEN AIR LEAK TESTED PER NAVILYST MEDICAL PROCEDURES, AND PASSED. THE REPORTED PROBLEM OF AIR ENTRY WAS UNABLE TO BE CONFIRMED, AS THE SAMPLE FROM THE REPORTED EVENT HAD BEEN DISCARDED. THE RETURNED SAMPLE, ALSO FROM THE REPORTED LOT, WAS FOUND TO BE VISUALLY AND FUNCTIONALLY ACCEPTABLE. IT IS POSSIBLE THAT THE END USER DID NOT ADEQUATELY SECURE THE CONNECTION BETWEEN THE CIL AND THE DEVICE TO WHICH IT WAS ATTACHED. THE DIRECTIONS FOR USE PROVIDED WITH THE PML CONTAINS THE CAUTION, "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."

    Description of Event or Problem · 1

    HOSPITAL REPORTED VISUALIZING AIR BUBBLES WITH A NAVILYST MEDICAL HIGH PRESSURE CONTRAST INJECTION LINE WITH MALE ROTATING ADAPTOR DURING A PROCEDURE. THEY BELIEVED THAT THE AIR BUBBLES WERE COMING FROM THE ROTATING ADAPTOR. THERE WAS NO AIR INJECTION OR PATIENT INJURY. THE USED DEVICE WAS DISCARDED AT THE HOSPITAL, HOWEVER THEY RETURNED AN UNUSED DEVICE FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131076 NAVILYST MEDICAL HIGH PRESSURE CONTRAST INJECTION LINE DXT NAVILYST MEDICAL NA 4828496

    Patients

    Seq Age Sex Outcome Treatment
    1