BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV 2100 B VACUUM RELIEF VALVE

    MDR report key: 4906307 · Received July 10, 2015

    Report

    Report Number
    1649914-2015-00048
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED TWO SAMPLES IN ONE BAG FROM THE CUSTOMER, ONE WAS ASSIGNED TO CC15-169 AND THE OTHER TO CC15-170. IT IS UNKNOWN WHAT LOT NUMBER THE SAMPLES ARE FROM. THE SAMPLE FOR CC15-169 WAS TESTED ON (B)(6) 2015. THE SAMPLE WAS ATTACHED TO 48" WATER HEAD HEIGHT WHICH IS APPROXIMATELY 1.73 PSI (89.76MMHG), THE SAMPLE LEAKED AT THE UMBRELLA VALVE. THESE VALVES ARE DESIGNED FOR PRESSURE RELIEF AT A NEGATIVE PRESSURE OF -200MMHG AND AT A POSITIVE PRESSURE <1300MMHG. TO FURTHER INVESTIGATE THE ROOT CAUSE THE SAMPLE WAS CUT OPEN TO CHECK THE SEATING OF THE UMBRELLA VALVE AS IT WAS EVIDENT FROM THE AMOUNT OF LEAK THAT THE UMBRELLA VALVE IS NOT SEATED PROPERLY. AFTER CUTTING THE VALVE OPEN, IT WAS CONFIRMED THAT THE UMBRELLA VALVE WAS CURLED ON ONE SIDE CAUSING THE VALVE TO LEAK. A CPAR 15--2 HAD ALREADY BEEN IDENTIFIED AND OPENED TO ADDRESS THIS ISSUE FOR LEAKING VALVES. THE DEVICE HISTORY RECORDS OF LOT 047578, 047470 & 047264 WERE REVIEWED; THE INSPECTION REPORT SHOWED THAT NO DEFECT WAS FOUND AND REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUE WAS REPORTED SIMILAR TO THIS COMPLAINT CONDITION. LOT 047578 MANUFACTURE DATE: (B)(6) 2014 LOT 047470 MANUFACTURE DATE: (B)(6) 2014 LOT 047264 MANUFACTURE DATE: (B)(6) 2014

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WHILE USING THE SUCTION CONTROL VALVE. THIS VALVE IS SOLD BY THE MANUFACTURER AS AN OEM DEVICE TO THE DISTRIBUTOR FOR FURTHER PROCESSING/STERILIZATION. THE REPORT STATED THAT THE PERFUSIONIST OBSERVED THE DEVICE LEAKING DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INFORMATION PROVIDED. THERE WERE NO ACTIONS TAKEN DURING THE PROCEDURE AS A RESULT OF THE ALLEGED EVENT. THE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THE ALLEGED EVENT. THE DISTRIBUTOR AND THE CUSTOMER WERE UNSURE OF THE LOT NUMBER OF THE IMPLICATED PRODUCT BUT KNOW IT WAS ONE OF THREE POSSIBLE LOT NUMBERS. NONE OF THOSE LOTS REMAINS IN THE MANUFACTURER'S INVENTORY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450953 RLV 2100 B VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention