BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESIO CATHETER

    MDR report key: 374943 · Received February 1, 2002

    Report

    Report Number
    2518902-2002-00011
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    January 10, 2002
    Report Date
    January 11, 2002
    Manufacturer
    MEDCOMP MEDICAL COMPONENTS, INC.
    Product Code
    LFJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FAICLITY THAT WHILE THE PATIENT WAS RECEIVING A DIALYSIS TREATMENT, THE SIDE OF THE "TESIO CATHETER BLEW OUT". THE CATHETER WAS CLAMPED NEAR THE EXIT SITE. THE PATIENT LOST APPROX 200-300CC OF BLOOD. THE PATIENT WAS TRANSFERRED TO THE ER FOR REMOVAL AND REPLACEMENT OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESIO CATHETER HEMODIALYSIS CATHETER LFJ MEDCOMP MEDICAL COMPONENTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention