BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VRV-11C VACUUM RELIEF VALVE

    MDR report key: 2467148 · Received February 16, 2012

    Report

    Report Number
    1649914-2012-00002
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    November 30, 2011
    Report Date
    January 18, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC HAS LIMITED INFO 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 IN (B)(4) REPORTED THAT A VACUUM RELIEF VALVE LEAKED DURING A PROCEDURE AT A HOSP IN (B)(6). THE INFO PROVIDED INDICATED THE PT WAS A SMALL CHILD WHO MAY HAVE LOST BLOOD DURING THE PROCEDURE AS A RESULT OF THE ALLEGED EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND NO OTHER IMPACT TO THE PT REPORTED. THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. ATTEMPTS TO OBTAIN ADD'L INFO WERE NOT SUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRV-11C VACUUM RELIEF VALVE SUCTION CONTROL, INTRACARDIAC, CARGIOBYPASS DTR QUEST MEDICAL, INC. 4004203 037602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention