BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFTEY VALVE

    MDR report key: 794190 · Received November 30, 2006

    Report

    Report Number
    1649914-2006-00140
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Report Date
    November 29, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY FOUND A CRACK IN THE RETROGUARD BODY. TWELVE SAMPLES WERE SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE 4007200; LOT NUMBER 24724.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD ARTERIAL SAFTEY VALVE FLOW CHECK VALVE MJJ QUEST MEDICAL, INC. 4007200 24724

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN