BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 7294368 · Received February 24, 2018

    Report

    Report Number
    1649914-2018-00023
    Event Type
    Malfunction
    Date Received
    February 24, 2018
    Report Date
    February 23, 2018
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    MJJ
    PMA / PMN Number
    K922356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS EVALUATED AND A LONGITUDINAL CRACK WAS SEEN ON THE HOUSING OF THE VALVE. THE NATURE OF THE CRACK SUGGESTS THAT THE CRACK MAY HAVE RESULTED FROM A BLUNT FORCE IMPACT ON THE DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE INVOLVES A 100% VISUAL AND FUNCTIONAL INSPECTION. EACH DEVICE IS ALSO FUNCTIONALLY TESTED FOR LEAK, FORWARD FLOW AND RETROGRADE FLOW. NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER TO ENABLE A DHR REVIEW. HOWEVER, A 24 MONTHS COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE PART NUMBER AND NO SIMILAR COMPLAINT WAS IDENTIFIED. THIS COMPLAINT IS AN ISOLATED INCIDENT AND THE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM A CUSTOMER STATES THAT A CRACK WAS SEEN ON THE RETROGUARD VALVE DURING PRIME. THE ALLEGED ISSUE DID NOT RESULT IN ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138317 RETROGUARD ARTERIAL SAFETY VALVE CPB CHECK VALVE MJJ QUEST MEDICAL, INC 4007100

    Patients

    Seq Age Sex Outcome Treatment
    1