BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVA3XI - ADVANCED VENOUS ACCESS DEVICES

    MDR report key: 7046972 · Received November 20, 2017

    Report

    Report Number
    2015691-2017-03950
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 27, 2017
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYB
    PMA / PMN Number
    K981909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE COMPLAINT INVESTIGATION RESULTS. A DEVICE HISTORY RECORDS REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, A SMALL LEAK WAS NOTICED IN THE BACK FORM OF THE AVA INTRODUCER (WHERE THE 15 GAUGE LUMEN IS CONNECTED), WHILE INJECTING FLUID THROUGH THE LUMEN. THE ISSUE WAS RESOLVED BY REPLACING THE INTRODUCER, THE GUIDEWIRE, AND THE CATHETER WITH A NEW SET. THIS REQUIRED A NEW STICK. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT ABLE TO BE PROVIDED BY THE CUSTOMER, PER POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823820 AVA3XI - ADVANCED VENOUS ACCESS DEVICES INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES, PR M3L9FSI 60967375

    Patients

    Seq Age Sex Outcome Treatment
    1