BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV-2100B VACUUM RELIEF VALVE

    MDR report key: 4423646 · Received January 15, 2015

    Report

    Report Number
    1649914-2015-00004
    Event Type
    Injury
    Date Received
    January 15, 2015
    Date of Event
    December 22, 2014
    Report Date
    January 24, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    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 FOREIGN DISTRIBUTOR (B)(4) REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WITH THE VACUUM RELIEF VALVE. IT WAS REPORTED THAT THE VENT VALVE LEAKED DURING A PROCEDURE. THE LEAKED FLUID TYPE AND VOLUME WAS NOT REPORTED. THE COMPLAINANT REPORTED THAT THE LEAK APPEARED TO ORIGINATE FROM THE VENT ORIFICE AT THE TOP OF THE VALVE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE DISTRIBUTOR OR MANUFACTURER FOR ANALYSIS. SEE ALSO 1649914-2015-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35023 RLV-2100B VACUUM RELIEF VALVE CPBP VACUUM RELIEF VALVE DWD QUEST MEDICAL, INC. 4103102 0472654G03

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention