BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV II VACUUM RELIEF VALVE

    MDR report key: 7011809 · Received November 8, 2017

    Report

    Report Number
    1649914-2017-00075
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    August 30, 2017
    Report Date
    November 8, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    UDI-DI
    10634624442037
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DHR FOR THE DEVICE WAS REVIEWED AND NO NON-CONFORMITIES OR DEVIATIONS WERE ASSOCIATED WITH THE MANUFACTURING OF THE DEVICE. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED AN ISSUE WITH THE CPBP VACUUM RELIEF VALVE. THIS VALVE WAS INTEGRATED INTO A SUCKER LINE IN OUR CARDIOVASCULAR TUBING KIT. THE REPORT STATES THAT THE VALVE GOT STUCK DURING USE BY THE DISTRIBUTOR'S CUSTOMER AND WASN'T SUCKING ANY BLOOD. THIS OCCURRED DURING A PROCEDURE, BUT WHEN THEY APPLIED SOME PRESSURE ON THE VALVE, IT CLICKED AND STARTED WORKING. THERE WAS NO DELAY TO THE PROCEDURE, NO PATIENT INJURY, AND NO BLOOD LOSS WAS REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791506 VRV II VACUUM RELIEF VALVE CPBP VACUUM RELIEF VALVE DWD QUEST MEDICAL, INC. 4004203 053717 10634624442037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention