BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POURCHEZ XPRESSO

    MDR report key: 489439 · Received October 8, 2003

    Report

    Report Number
    1223643-2003-00004
    Event Type
    Malfunction
    Date Received
    October 8, 2003
    Date of Event
    September 9, 2003
    Report Date
    October 8, 2003
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER SPLIT Y-JOINT DURING INSERTION INTO PEEL-AWAY SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POURCHEZ XPRESSO CHRONIC HEMODIALYSIS CATHETER MSD SPIRE BIOMEDICAL, INC. SK23SH28 99364341

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other