BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 773358 · Received August 14, 2006

    Report

    Report Number
    1649914-2006-00065
    Event Type
    Malfunction
    Date Received
    August 14, 2006
    Report Date
    August 11, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRIME, THEIR END CUSTOMER FOUND A CRACK RUNNING HALFWAY DOWN THE SIDE OF THE HOUSING. THE SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE 4007200; LOT NUMBER 26074.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD ARTERIAL SAFETY VALVE FLOW CHECK VALVE MJJ QUEST MEDICAL, INC. 4007200 26074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN