BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGUARD

    MDR report key: 454913 · Received April 16, 2003

    Report

    Report Number
    1649914-2003-00013
    Event Type
    Malfunction
    Date Received
    April 16, 2003
    Report Date
    April 16, 2003
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VALUE WAS RETURNED FROM THE KIT PACKER'S CUSTOMER BECAUSE THE CUSTOMER COULD NOT ESTABLISH FLOW THROUGH THE VALVE. THERE APPEARED TO BE NO SLIT IN THE DUCKBILL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *