BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRV-II VACUUM RELIEF VALVE

    MDR report key: 6128194 · Received November 27, 2016

    Report

    Report Number
    1649914-2016-00063
    Event Type
    Malfunction
    Date Received
    November 27, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    UDI-DI
    20634624432035
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS VISUALLY INSPECTED WITH NO ANOMALIES FOUND. TO SIMULATE THE REPORTED COMPLAINT CONDITION, THE VALVE WAS CONNECTED TO HEISE GAUGE AND TESTED AT ROLLER PUMP SPEED OF 0.5L/MIN, 1L/MIN AND 2L/MIN. AT ALL SPEEDS THE VALVE OPENED AT NEGATIVE PRESSURE OF 149MMHG AND POSITIVE PRESSURE OF 342MMHG. THE REPORTED COMPLAINT CONDITION COULD NOT BE DUPLICATED. THE DEVICE HISTORY RECORDS FOR THE APPLICABLE LOT OF PRODUCT WERE REVIEWED AND THE INSPECTION REPORT SHOWED THAT NO DEFECT WAS FOUND AND REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUE WAS REPORTED SIMILAR TO THIS COMPLAINT CONDITION. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY THE CUSTOMER WHEN USING THE VACUUM RELIEF VALVE. THE REPORT STATED THAT THE VALVE "WOULDN'T ALLOW AIR THROUGH TO PROVIDE PRESSURE RELIEF AND BLOOD FLOW THROUGH WAS POOR". FOLLOW-UP WITH THE COMPLAINANT FOUND THAT THEY REMOVED THE DEVICE FROM USE AND REPLACED IT WITH ANOTHER. THERE WAS NO ADDITIONAL BLOOD LOSS FROM THE USUAL THE CHANGE OUT OF VALVE PROLONGED THE PROCEDURE BY APPROXIMATELY 5 MINUTES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778874 VRV-II VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4003203 050044 20634624432035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention