BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL CATHETER

    MDR report key: 447719 · Received March 7, 2003

    Report

    Report Number
    2518902-2003-00029
    Event Type
    Malfunction
    Date Received
    March 7, 2003
    Report Date
    February 12, 2003
    Manufacturer
    MEDCOMP
    Product Code
    LFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE DISTAL END OF THE CATHETER CRACKS DURING INTRODUCTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL CATHETER HEMODIALYSIS CATHETER LFK MEDCOMP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention