BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV 2100 B VACUUM RELIEF VALVE

    MDR report key: 4906464 · Received July 10, 2015

    Report

    Report Number
    1649914-2015-00049
    Event Type
    Injury
    Date Received
    July 10, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    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 (B)(4) AND THE OTHER TO (B)(4) . IT IS UNKNOWN WHAT LOT NUMBER THE SAMPLES ARE FROM. THE SAMPLE FOR CC15-170 AND WAS TESTED ON (B)(6) 2015. THE SAMPLE WAS ATTACHED TO 48" WATER HEAD HEIGHT WHICH IS APPROXIMATELY 1.73 PSI (89.76MMHG), NO LEAK WAS SEEN, THE SAMPLE FUNCTIONED AS DESIGNED. THESE VALVES ARE DESIGNED FOR PRESSURE RELIEF AT A NEGATIVE PRESSURE OF -200MMHG AND AT A POSITIVE PRESSURE <1300MMHG. THE COMPLAINT CONDITION FOR THIS SAMPLE WAS NOT CONFIRMED. A CPAR 15--2 HAD ALREADY BEEN IDENTIFIED AND OPENED TO ADDRESS THE ALLEGED COMPLAINT 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: 09/18/2014 LOT 047470 MANUFACTURE DATE: 09/03/2014 LOT 047264 MANUFACTURE DATE: 08/26/2014

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR (SINGAPORE) 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
    449302 RLV 2100 B VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103202

    Patients

    Seq Age Sex Outcome Treatment
    1