BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.5FX24CM HEMO-CATH

    MDR report key: 2972023 · Received February 15, 2013

    Report

    Report Number
    2518902-2013-00009
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    PINHOLES WERE FOUND IN THE CATHETER EXTENSION TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69455 12.5FX24CM HEMO-CATH HEMODIALYSIS CATHETER MSD MEDCOMP MC101243 MBLX910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention