BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH 3.5 FR

    MDR report key: 1736029 · Received June 7, 2010

    Report

    Report Number
    1736029
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 7, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS ATTEMPTING TO DISCONTINUE UMBILICAL ARTERY CATHETER AND WHILE PULLING GENTLY ON THE LINE, THE CATHETER SEPARATED BELOW THE SUTURE CLOSE TO UMBILICAL SITE. THIS RESULTED IN A BLOOD LOSS OF APPROXIMATELY 13 ML OF BLOOD, AND REQUIRED A TRANSFUSION OF 5 ML OF PACKED RED BLOOD CELLS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SEPARATION OF THE CATHETER RESULTED IN BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILI-CATH 3.5 FR CATHETER, UMBILICAL FOS UTAH MEDICAL PRODUCTS, INC. 4173505 110001 OR 1092513

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA OTHER