BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE PLEGIAGUARD CARDIOPLEGIA S

    MDR report key: 794199 · Received November 30, 2006

    Report

    Report Number
    1649914-2006-00147
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 13, 2006
    Report Date
    November 29, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MJJ
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, WHEN GETTING READY TO COME OFF BYPASS THE "TUBING BECAME DISCONNECTED FROM THE VALVE." NO SAMPLES WERE SAVED. PRODUCT CODE 4007100; LOT NUMBER 27182.L13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD ARTERIAL SAFETY VALVE PLEGIAGUARD CARDIOPLEGIA S CPBP ADAPTER, STOPCOCK, MANIFOLD OR FITTING MJJ QUEST MEDICAL, INC. 4007100 27182.L13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN