BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 4254760 · Received November 7, 2014

    Report

    Report Number
    1317056-2014-00075
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    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 LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SEPTEMBER 2014 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT AND CONTRAST INJECTION LINE PRODUCT FAMILIES AND THE FAILURE MODE "CONTAMINATION IN FLUID PATH". NO ADVERSE TRENDS WERE IDENTIFIED. RETURNED FOR EXAMINATION WAS A BONDED ASSEMBLY CONSISTING OF A STOPCOCK AND A CONTRAST INJECTION LINE (CIL). LOOSE WITHIN THE FEMALE LUER OF THE CIL WAS WHAT APPEARED TO BE A PIECE OF FOAM, WHEN VIEWED UNDER MAGNIFICATION. THE ISSUE WAS BROUGHT TO THE ATTENTION OF THE MFG DEPARTMENT, HOWEVER THE SOURCE OF THE CONTAMINATION WAS UNABLE TO BE IDENTIFIED. THIS IS CONSIDERED TO BE IN ISOLATED INCIDENT AND IS THE ONLY REPORTED COMPLAINT FOR THIS FAILURE MODE IN THE PAST 15 MONTHS. MFG PROCESS CONTROLS FOR CONVENIENCE KIT PACKAGING INCLUDE THE REQUIREMENT TO PERFORM A 100% INSPECTION FOR FOREIGN MATTER UNDER A MAGNIFICATION LAMP. ADDITIONALLY ALL KIT POUCHES ARE VISUALIZED FOR FOREIGN MATTER DURING THE SEALING PROCESS.

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(4), LOOSE FOREIGN MATTER WAS NOTED WITHIN THE FEMALE LUER (FLUID PATH) OF A CONTRAST INJECTION LINE PACKAGED WITHIN A CONVENIENCE KIT. THE PRODUCT HAD NOT YET BEEN DISTRIBUTED TO A HOSPITAL AND HAS BEEN RETURNED TO NAVILYST MEDICAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718480 NAVILYST MEDICAL CONVENIENCE KIT OEZ NAVILYST MEDICAL NA 4784999

    Patients

    Seq Age Sex Outcome Treatment
    1