BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POURCHEZ XPRESS0

    MDR report key: 495358 · Received November 10, 2003

    Report

    Report Number
    1223643-2003-00007
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Date of Event
    October 2, 2003
    Report Date
    November 10, 2003
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS DAMAGED AFTER TUNNELING, WHILE ATTEMPTING TO REMOVE THE TUNNELING STYLE FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POURCHEZ XPRESS0 CHRONIC HEMODIALYSIS CATHETER MSD SPIRE BIOMEDICAL, INC. XM23SH28 99325751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other