BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VRV-11C VACUUM RELIEF VALVE

    MDR report key: 3164430 · Received June 7, 2013

    Report

    Report Number
    1649914-2013-00033
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE DISTRIBUTOR REPORTED THAT A VACUUM RELIEF VALVE LEAKED DURING A PROCEDURE AT A HOSPITAL. THE INFORMATION PROVIDED INDICATED THAT THE ONE-WAY VALVE LEAKED AT THE DOME DURING USE. IT WAS REPORTED THAT THE VALVE WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253390 VRV-11C VACUUM RELIEF VALVE SUCTION CONTROL, INTRACARDIAC, CARDIOBYPASS DWD QUEST MEDICAL, INC. 4003203 042812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention