BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F X 18CM HEMO-CATH

    MDR report key: 2972025 · Received February 15, 2013

    Report

    Report Number
    2518902-2013-00010
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 17, 2013
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SMALL HOLE DEVELOPED NEAR THE CENTER OF THE VENOUS EXTENSION TUBE. WHEN PRESSURE EXCEEDS 200, THE HOLE LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69690 8F X 18CM HEMO-CATH HEMODIALYSIS CATHETER MSD MEDCOMP SL18P MBLQ040

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR