BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIO-PAK

    MDR report key: 13218 · Received May 12, 1994

    Report

    Report Number
    MW1001957
    Event Type
    Malfunction
    Date Received
    May 12, 1994
    Date of Event
    April 14, 1994
    Report Date
    May 11, 1994
    Manufacturer
    GUIDEWIRES TECHNOLOGIES, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SOME OF THE TEFLON COATING ON THE GUIDE WIRE WAS FLAKING OFF, EITHER DURING INSERTION OR REMOVAL THROUGH AN 18 GA NEEDLE. THE PT WAS NOT INJURED. THE RPTR STATED THAT UPON HANDLING A NEW CATHETER, SHE NOTED THAT THE TEFLON COATING DOES FLAKE OFF EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIO-PAK GUIDE WIRE DQX GUIDEWIRES TECHNOLOGIES, INC. C294BA0800

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR