BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLEX TESIO CATHETER

    MDR report key: 705485 · Received April 24, 2006

    Report

    Report Number
    2518902-2006-00017
    Event Type
    Malfunction
    Date Received
    April 24, 2006
    Date of Event
    March 9, 2006
    Report Date
    April 21, 2006
    Manufacturer
    MEDCOMP
    Product Code
    LFG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "DURING THE REGULAR SITE CARE THE NURSE NOTICED THE CATHETER HAD BEEN CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFLEX TESIO CATHETER HEMODIALYSIS CATHETER LFG MEDCOMP BFR1035KD-A MACD680

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other