BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 1190599 · Received October 3, 2008

    Report

    Report Number
    1317056-2008-00076
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT HAS BEEN INDICATED THAT THE REPORTED DEVICE WAS DISPOSED OF BY THE END USER AND WOULD NOT BE AVAILABLE FOR RETURN, WE ARE CURRENTLY CONDUCTING AN INVESTIGATION INTO THE EVENT. THE RESULTS OF WHICH WILL BE REPORTED IN A FOLLOW UP MEDWATCH.

    Description of Event or Problem · 1

    AS REPORTED BY THE DISTRIBUTOR, THE END USER NOTICED AIR BUBBLES IN THE MANIFOLD. NO AIR WAS INJECTED INTO THE PATIENT AND CONSEQUENTLY THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL MANIFOLD FMG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1