BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUUM RELIEF VALVE II-C

    MDR report key: 3812642 · Received May 6, 2014

    Report

    Report Number
    1649914-2014-00020
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW AND ADDITIONAL DEVICE ANALYSIS ARE STILL UNDERWAY TO INVESTIGATE THE SOURCE OF THE ALLEGED LEAK. 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 FOREIGN DIST (B)(6) NOTIFIED THE MFR OF AN ISSUE ENCOUNTERED WITH THE VRV-IIC VACUUM RELIEF VALVE. THE DISTRIBUTOR REPORTED THAT THEIR CUSTOMER (HOSP) ENCOUNTERED A LEAK DURING A PROCEDURE USING THE VALVE. THEY REPORTED AN APPROXIMATE 50-100ML PT BLOOD LOSS AS A RESULT OF THE ALLEGED EVENT. THERE WAS NO OTHER PT IMPACT REPORTED. THE HOSP PERSONNEL REMOVED THE VALVE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271581 VACUUM RELIEF VALVE II-C CPBP SUCTION CONTROL, INTRACARDIAC DWD QUEST MEDICAL, INC. 4004203 045395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention