BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14F 28CM SPLIT STREAM

    MDR report key: 3190694 · Received June 21, 2013

    Report

    Report Number
    2518902-2013-00031
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHEN INJECTING FLUIDS INTO THE LUMEN, IT FLOWS BACK FROM THE CATHETER TUNNEL. AFTER REMOVAL A CRACK IN THE INTERNAL PORTION OF THE LUMEN WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283383 14F 28CM SPLIT STREAM HEMODIALYSIS CATHETER MSD MEDCOMP SST28E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention