BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV-II (NON-STERILE)

    MDR report key: 178437 · Received July 20, 1998

    Report

    Report Number
    1627487-1998-00024
    Event Type
    Malfunction
    Date Received
    July 20, 1998
    Date of Event
    May 1, 1998
    Report Date
    July 20, 1998
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PORT ON THE VALVE BROKE OFF WHEN THE CUSTOMER WAS ATTEMPTING TO ATTACH THE VALVE. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRV-II (NON-STERILE) VACUUM RELIEF VALVE MNJ QUEST MEDICAL, INC. 4003203 8230

    Patients

    Seq Age Sex Outcome Treatment
    1 *