BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SYSTEM

    MDR report key: 2830171 · Received November 6, 2012

    Report

    Report Number
    MW5027566
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 6, 2012
    Manufacturer
    QUEST MEDICAL INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WATER TO BLOOD LEAK NOTICED IN TWO DISPOSABLE CDPG TUBING SYSTEM WITH THE SAME LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBING SYSTEM CDPG TUBING DWF QUEST MEDICAL INC. 0424462U02

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR