BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.5 FR PVC UVC WITH HUB

    MDR report key: 497583 · Received November 25, 2003

    Report

    Report Number
    1314426-2003-00010
    Event Type
    Other
    Date Received
    November 25, 2003
    Date of Event
    November 10, 2003
    Report Date
    November 25, 2003
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FOS
    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 TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH AN UMBILICAL VESSEL CATHETER. THE CUSTOMER REPORTS THAT BLEEDING WAS NOTED, AND AN XRAY WAS PERFORMED WHICH REVEALED A BROKEN CATHETER. THE CATHETER WAS REMOVED, AND FOUND TO BE BROKEN ABOUT 9-10CM FROM THE DISTAL END. THE PATIENT REQUIRED A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5 FR PVC UVC WITH HUB UMBILICAL VESSEL CATHETER FOS TYCO HEALTHCARE/KENDALL * 430849

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R