BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VRV-11C VACUUM RELIEF VALVE

    MDR report key: 3445287 · Received October 29, 2013

    Report

    Report Number
    1649914-2013-00061
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 1, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE DEVICE DISTRIBUTOR REPORTED THAT A VACUUM RELIEF VALVE LEAKED DURING A PROCEDURE AT A DOMESTIC HOSPITAL. IT WAS REPORTED THAT THE ALLEGED EVENT OCCURRED WHILE THE PT WAS ON BYPASS. THE INFORMATION PROVIDED INDICATED BLOOD LOSS OF APPROXIMATELY 100-150 CC AS A RESULT OF THE ALLEGED EVENT. THE REPORT STATED THAT THE LEAK APPEARED TO ORIGINATE FROM THE CAP OF THE VALVE. THERE WERE NO FURTHER COMPLICATIONS OR DELAYS REPORTED AND NO OTHER IMPACT TO THE PT REPORTED. THE DISTRIBUTOR'S INTERNAL TESTING OF THE DEVICE FOUND THAT THE VALVE LEAKS AT A PRESSURE OF ABOUT 1 PSI. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554807 VRV-11C VACUUM RELIEF VALVE SUCTION CONTROL, INTRACARDIAC, CARDIOBYPASS DWD QUEST MEDICAL, INC. 4004203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention