BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 7538970 · Received May 23, 2018

    Report

    Report Number
    1649914-2018-00046
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Report Date
    August 17, 2018
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    MJJ
    PMA / PMN Number
    K922356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE IS SOLD BULK, NON-STERILE TO THE CUSTOMER FOR FURTHER PROCESSING INTO FINAL STERILE PACKS. DEVICE EVALUATION COULD NOT BE CONDUCTED AS THE COMPLAINT SAMPLE WAS NOT RETURNED. A DHR REVIEW WAS CONDUCTED AND SHOWED NO MANUFACTURING ANOMALIES RELATED TO THE REPORTED COMPLAINT CONDITION. THE ROOT CAUSE OF THE ALLEGED ISSUE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. 10UNITS OF DEVICES FROM ANOTHER LOT WERE EVALUATED. TO DEMONSTRATE THE SCENARIO, THE DEVICES WERE CONNECTED TO A ROTARY PUMP AND SUBJECTED TO A FORWARD FLOW OF 1.0 L/MIN. DURING THE PROCESS, A HEMOSTAT WAS USED TO REPLICATE THE CRACK BY SUBJECTING THE VALVE TO BLUNT FORCE UNTIL THE AIR BUBBLES DISAPPEAR. 3 OUT OF THE 10 VALVES GENERATED THE CRACK SIMILAR TO THE ONE SEEN IN THE PICTURE SENT BY THE CUSTOMER. SUBJECTING THE VALVE TO BLUNT FORCE CAN CAUSE CRACKS TO GENERATE ON THE WELD LINE. AS A PROACTIVE MEASURE, THE MELT TEMPERATURE FOR THE VALVES MOLDING PROCESS WILL BE INCREASED TO 517°F TO MINIMIZE ANY CRACKS DEVELOPING FROM APPLICATION OF HEMOSTATS BY USERS.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM A CUSTOMER STATES THAT THE VALVE LEAKED DURING USE AND HAD TO BE CUT FROM THE CIRCUIT. THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380810 RETROGUARD ARTERIAL SAFETY VALVE CPB CHECK VALVE MJJ QUEST MEDICAL, INC 4007200 054709

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention