BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 7102512 · Received December 8, 2017

    Report

    Report Number
    1649914-2017-00102
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    October 27, 2017
    Report Date
    January 26, 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 MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND PRESENCE OF PARTICULATE MATTER WAS CONFIRMED. 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. PARTICULATE COUNT, TEMPERATURE AND HUMIDITY IN THE CLEAN ROOM IS CONSTANTLY MONITORED IN ACCORDANCE WITH INTERNAL ENVIRONMENTAL MONITORING PROCEDURES. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. 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 FOREIGN MATTER COLORED IN BLACK IN 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
    881645 RETROGUARD ARTERIAL SAFETY VALVE CPB CHECK VALVE MJJ QUEST MEDICAL, INC 4007100 0530017F07

    Patients

    Seq Age Sex Outcome Treatment
    1