BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 3221489 · Received July 2, 2013

    Report

    Report Number
    1317056-2013-00024
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH ALL USED SAMPLES WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. NAVILYST MEDICAL'S INVESTIGATION INTO THIS EVENT IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED, THE END USER OBSERVED AIR IN THE MANIFOLD SYSTEM OF A CONVENIENCE KIT DURING AN INTERVENTION PROCEDURE. NO AIR WAS INJECTED AND NO PT INJURY OCCURRED. THIS IS THE 2ND TIME THE HOSPITAL HAS HAD THIS OCCUR. THEY BELIEVE THAT THE AIR IS BEING PULLED IN DURING ASPIRATION OF CONTRAST WITH A 10CC SYRINGE. ALL USED SAMPLES WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300501 NAVILYST MEDICAL CONVENIENCE KIT DQX NAVILYST MEDICAL NA 4642545

    Patients

    Seq Age Sex Outcome Treatment
    1