BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC VASCULAR ACCESS CATHETER

    MDR report key: 34423 · Received July 24, 1996

    Report

    Report Number
    MW1009554
    Event Type
    Malfunction
    Date Received
    July 24, 1996
    Date of Event
    February 15, 1995
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BARD ACCESS SYSTEMS, INC. 5425 W AMELIA EARHART DR, SALT LAKE CITY, UT 84116. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND SO NO FAILURE ANALYSIS HAS BEEN DONE ON THE PRODUCT. AS NEITHER PRODUCT NUMBER NOR LOT NUMBER WERE AVAILABLE FOR THIS DEVICE, CO WAS UNABLE TO CONDUCT A DEVICE HISTORY REVIEW. CO HAS INSUFFICIENT INFO TO DETERMINE WHETHER OR NOT THE INCIDENT WAS ATTRIBUTABLE TO THE DEVICE. EXPECTED FREQUENCY: 4 INCIDENTS/YEAR, OBSERVED FREQUENCY: 3 INCIDENTS/YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC VASCULAR ACCESS CATHETER Implant VASCULAR ACCESS CATHETER DQO BARD ACCESS SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO