BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 7115416 · Received December 13, 2017

    Report

    Report Number
    1649914-2017-00109
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 23, 2017
    Report Date
    January 17, 2018
    Manufacturer
    QUEST MEDICAL, INC
    Product Code
    MJJ
    PMA / PMN Number
    K922356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT COMPLICATION RESULTING FROM THE ALLEGED ISSUE. THE DEVICE WILL BE INVESTIGATION AND A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    FOLLOWING VISUAL INSPECTION OF THE DEVICE, FIBER LIKE PARTICULATE WAS SEEN IN THE FLUID PATH OF THE COMPONENT. QUEST MEDICAL HAS IMPLEMENTED SEVERAL CONTROLS TO PREVENT THIS ISSUE INCLUDING MAINTENANCE OF AN ISO CLASS 8 MANUFACTURING ENVIRONMENT, EMPLOYEE GOWNING AND UNIFORM PROCEDURES, ROUTINE CLEANING, BATCH TO BATCH LINE CLEARANCE ACTIVITIES AND MANUFACTURING SURFACE CLEANING. THE DHR FOR THIS DEVICE WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED. THE ROOT CAUSE IS UNKNOWN. AS A PROACTIVE MEASURE, QUEST MEDICAL HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE. NO FURTHER SUPPLEMENTS WILL BE SUBMITTED UNLESS NEW SIGNIFICANT FINDINGS EMERGE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH THE VALVE. THE REPORT STATES THAT DURING A CIRCUIT ASSEMBLING AN OPERATOR FOUND TWO OF FIBERLY DUSTS COLORED IN BLACK IN THE RETROGUARD HOUSING THE RETROGUARD HOUSING. THE OPERATOR ELECTED NOT TO USE THE VALVE FOR THE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891684 RETROGUARD ARTERIAL SAFETY VALVE CPB CHECK VALVE MJJ QUEST MEDICAL, INC 4007100 0530017F07

    Patients

    Seq Age Sex Outcome Treatment
    1