BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONO CATH B. CANAUD METHOD

    MDR report key: 370029 · Received January 4, 2002

    Report

    Report Number
    2518902-2001-00218
    Event Type
    Injury
    Date Received
    January 4, 2002
    Date of Event
    November 21, 2001
    Report Date
    December 13, 2001
    Manufacturer
    MEDCOMP MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DISCONNECTION OF THE CATHETER AT THE HARD CONNECTING PIECE. THE CATHETER THEN MIGRATED TO THE VENA CAVA AND HAD TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONO CATH B. CANAUD METHOD HEMODIALYSIS CATHETER LFJ MEDCOMP MEDICAL COMPONENTS, INC. NA M033580

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention