BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 3232386 · Received May 15, 2013

    Report

    Report Number
    3232386
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 15, 2013
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSE WENT TO PUT BABY BACK TO BED AFTER MOM HOLDING FOR 1 HOUR. THE NURSE SAW 4 DROPS OF BLOOD ON THE PILLOW, THEN SAW BLOOD OOZING FROM UMBILICAL ARTERY CATHETER (UAC) WHERE IT CONNECTS TO THE HUB. THE UAC WAS THEN CLAMPED AND REMOVED PER PROTOCOL, WITH THE CATHETER INTACT EXCEPT FOR HOLE AT HUB.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UAC.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216109 UMBILI-CATH CATHETER FOS UTAH MEDICAL PRODUCTS 4173505 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *