BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD ARTERIAL SAFETY VALVE

    MDR report key: 742733 · Received July 21, 2006

    Report

    Report Number
    1649914-2006-00049
    Event Type
    Malfunction
    Date Received
    July 21, 2006
    Date of Event
    May 17, 2006
    Report Date
    July 20, 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 DURING INCOMING INSPECTION OF QUEST LOT NUMBER 24871, A DEVICE WAS FOUND WITH A LONG CRACK IN THE BODY. THE SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE 4007200 LOT NUMBER 24871.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGUARD ARTERIAL SAFETY VALVE FLOW CHECK VALVE MJJ QUEST MEDICAL, INC. 4007200 24871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN