BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV-2100 B NONSTERILE SUCTION CONTROL VALVE

    MDR report key: 4138052 · Received October 3, 2014

    Report

    Report Number
    1649914-2014-00047
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 10, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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 THEY RECEIVED A CUSTOMER COMPLAINT REGARDING A QUEST PERFUSION VALVE INCLUDED IN THEIR CUSTOM PACK. THE DISTRIBUTOR'S CUSTOMER INDICATED THAT THE SUCTION CONTROL (VACUUM RELIEF, ONE-WAY VALVE) HAD LEAKED DURING A PROCEDURE. IT WAS REPORTED THAT THE CLEAR SILICONE SLEEVE OF THE VALVE HAD SLIPPED OFF AND THERE WAS A PATIENT BLOOD LOSS OF APPROXIMATELY 100 MLS. THE REPORT STATED NO MEDICAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. DISTRIBUTOR VISUAL ANALYSIS OF THE DEVICE FOUND BLOOD UNDERNEATH THE PRESSURE BAND, AND TESTING FOUND THE DEVICE RELIEVED PRESSURE AT 400MMHG (BELOW SPECIFICATION). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618654 RLV-2100 B NONSTERILE SUCTION CONTROL VALVE PERFUSION SAFETY VALVE DWD QUEST MEDICAL, INC. 4103202 045195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention