BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK TPN SINGLE LUMEN CATHETER SET

    MDR report key: 1071849 · Received July 8, 2008

    Report

    Report Number
    1820334-2008-00348
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    October 9, 2006
    Report Date
    June 16, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE VALIDITY OF THIS REPORT. HOWEVER, WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT THE USERS NOTICED HOLES ON SOME PART OF THE CATHETERS AND THE PATIENT HAD EVIDENCE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK TPN SINGLE LUMEN CATHETER SET DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA F1965521

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK