BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 3061398 · Received March 27, 2013

    Report

    Report Number
    1317056-2013-00013
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR ITEM NUMBER IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTING CUSTOMER IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE FEBRUARY 2013 NAVILYST MEDICAL COMPLAINT REPORT WAS PERFORMED FOR THE PRODUCT FAMILIES OF CONVENIENCE KITS AND CONTRAST CONTROLLERS AND THE FAILURE MODES OF "AIR IN THE SYSTEM" AND "AIR BUBBLES." NO ADVERSE TRENDS WERE IDENTIFIED. THE SALES REP PERFORMED IN-SERVICING AT THE HOSPITAL ON MARCH 21, 2013, HOWEVER THE END USER HAS DECIDED TO REVISE THEIR CONVENIENCE KIT TO REMOVE THE SQUEEZE CONTRAST CONTROLLER AND REPLACE IT WITH A CHAMBER-LESS VERSION OF A FLUID DELIVERY SET. THE COMPLAINT IS INCONCLUSIVE AS NO SAMPLES WERE RETURNED FOR EVALUATION AND THE SHR DID NOT REVEAL ANY QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. THE DIRECTIONS FOR USE FOR THE CONVENIENCE KIT AS WELL AS THE SQUEEZE CONTRAST CONTROLLER, WHICH ARE BOTH PACKAGED WITH THE KIT, CONTAINS STATEMENTS REGARDING ENSURING THAT SECURE CONNECTIONS ARE MADE TO PREVENT THE INTRODUCTION OF AIR INTO THE SYSTEM, AND TO: "EXAMINE PRODUCT CAREFULLY FOR THE PRESENCE OF ENTRAPPED AIR AND TO FULLY DE-BUBBLE PRIOR TO INJECTION." ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED BY A (B)(6) HOSPITAL, TWICE, WHEN UTILIZING A NAVILYST MEDICAL CONVENIENCE KIT, AIR BUBBLES WERE OBSERVED IN THE SYSTEM DURING PREP. THE HOSPITAL HAD RECENTLY REPLACED THE CONTRAST DELIVERY LINE IN THEIR KIT WITH A SQUEEZE CONTRAST CONTROLLER. THERE ARE 3 DOCTORS THAT WORK AT THIS FACILITY AND ONLY ONE OF THEM HAD THE AIR IN THE SYSTEM ISSUE DESCRIBED ABOVE. THE OTHER 2 DOCTORS HAVE BEEN USING THE KIT WITHOUT ANY ISSUES. AS THE PROBLEMS OCCURRED DURING PREP THE PATIENTS WERE NOT AFFECTED, I.E., NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. THE USED DEVICES WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127308 NAVILYST MEDICAL CONVENIENCE KIT LJS NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1