BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST

    MDR report key: 2070377 · Received April 19, 2011

    Report

    Report Number
    1317056-2011-00041
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K822100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 SPECS. THE (B)(6) 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF CONTRAST INJECTION LINES AND THE FAILURE MODE OF "FITTING DETACHED/DISRUPTED PROCEDURE." NO ADVERSE TRENDS WERE IDENTIFIED. THE RETURNED SAMPLE WAS VISUALLY EXAMINED AND THE ROTATING MALE ADAPTOR (R.A.) WAS FOUND TO BE DISCONNECTED FROM THE LINE. THE ROOT CAUSE FOR THIS ISSUE IS THAT THE ROTATING ADAPTOR WAS NOT ADEQUATELY SWAGED TO THE STEM CUP OF THE TUBING AND THE VISUAL INSPECTION REQUIREMENTS IN PLACE TO DETECT THIS FAILURE MODE WERE NOT FOLLOWED. MFG PROCESS CONTROLS FOR THIS DEVICE INCLUDE 100% VISUAL INSPECTION OF EACH SWAGED ROTATING ADAPTOR TO ENSURE THAT A PROPER SWAGE IS IN PLACE, PULL TESTING ON THE R.A., VERIFICATION THAT THE R.A. IS TURNING FREELY, AND FLEX TESTING. ADD'L AQL TESTING, INCLUDING AIR LEAK TESTING IS PERFORMED AT THE COMPLETION OF THE LOT. # PR01257.

    Description of Event or Problem · 1

    AS REPORTED, DURING A HIGH PRESSURE CONTRAST INJECTION, THE FITTING DETACHED FROM A NAVILYST FLEXCIL HIGH PRESSURE CONTRAST INJECTION LINE AND THE CONTRAST SPRAYED IN THE EYE OF ONE OF THE LAB TECHS. THE TECH WAS TREATED BY HAVING THEIR EYE CLEANED. NO ADD'L COMPLICATIONS WERE REPORTED. THE USED DEVICE WAS RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST CONTRAST INJECTION LINE FPA NAVILYST MEDICAL NA 4088955

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention