BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 2632593 · Received June 25, 2012

    Report

    Report Number
    1317056-2012-00022
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    May 16, 2012
    Report Date
    June 4, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DQO
    PMA / PMN Number
    K822100
    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)(4) 2012 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF CONTRAST INJECTION LINES (CIL) AND THE FAILURE MODE "AIR BUBBLES." NO ADVERSE TRENDS WERE IDENTIFIED. RETURNED BY THE HOSP WERE A USED 30 INCH CIL CONNECTED TO A USED MEDRAD INJECTOR SYRINGE. THE CONNECTION BETWEEN THE TWO DEVICES WAS VISUALIZED AND NO ANOMALIES WERE NOTED. AIR LEAK TESTING WAS PERFORMED ON THE CIL, PER NAVILYST SPECIFICATION, AND NO LEAKAGE OCCURRED. BOTH FITTINGS OF THE CIL WERE VERIFIED TO BE DIMENSIONALLY WITHIN SPECIFICATION, AND THE MALE TAPER OF THE INJECTOR SYRINGE WAS FOUND TO BE ACCEPTABLE. THE REPORTED COMPLAINT WAS NOT CONFIRMED, AS THE RETURNED DEVICES WERE TESTED AND VERIFIED TO FUNCTION AS INTENDED. A POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT SECURE CONNECTIONS WHEN ATTACHING THE 30" CIL TO THE MEDRAD POWER INJECTOR. THE DIRECTIONS FOR USE PACKAGED WITH THE NAVILYST MEDICAL CIL, CAUTIONS THE END USER TO: "ENSURE THAT YOU ARE MAKING SECURE CONNECTIONS WHEN USING THIS DEVICE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM." (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(4), WHEN ATTEMPTING A POWER INJECTION OF CONTRAST MEDIA, AIR WAS SEEN TO BE ENTERING THE SYRINGE OF THE MEDRAD INJECTOR MACHINE (SEEN MAN ZONE MASTER INJECTOR). THE SYRINGE WAS CONNECTED TO A NAVILYST MEDICAL 30" HIGH PRESSURE CONTRAST INJECTION LINE. NO AIR WAS INJECTED INTO THE PT. THE COMPONENTS WERE REPLACED, AND THE PROCEDURE CONTINUED. THE USED DEVICES HAVE BEEN RETURNED TO NAVILYST MEDICAL FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL HIGH PRESSURE CONTRAST INJECTION LINE DQO NAVILYST MEDICAL NA 4173615

    Patients

    Seq Age Sex Outcome Treatment
    1