BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVER PRESSURE VALVE

    MDR report key: 47309 · Received October 31, 1996

    Report

    Report Number
    1222008-1996-00058
    Event Type
    Malfunction
    Date Received
    October 31, 1996
    Date of Event
    October 1, 1996
    Report Date
    October 1, 1996
    Manufacturer
    BARD VASCULAR SYSTEM
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THE VALVE LEAKED LOOSING 10CC OF BLOOD. THE VALVE WAS CHANGED OUT WITH NO COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVER PRESSURE VALVE OPS MNJ BARD VASCULAR SYSTEM NA 43AG5117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN