BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-FLO CATHETER

    MDR report key: 82787 · Received April 3, 1997

    Report

    Report Number
    1217435-1997-00096
    Event Type
    Malfunction
    Date Received
    April 3, 1997
    Date of Event
    March 3, 1997
    Report Date
    March 4, 1997
    Manufacturer
    USCI DIV., C.R. BARD, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SHAFT OF THIS DEVICE RUPTURED. THE DEVICE WAS REMOVED AND REPLACED. THE PT IS REPORTED AS FINE. THE DEVICE IS NOT BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-FLO CATHETER ANGIOGRAPHY CATHETER DQO USCI DIV., C.R. BARD, INC. NA 08KG1107

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR