BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 5055992 · Received September 4, 2015

    Report

    Report Number
    5055992
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 25, 2015
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER CHANGING TPN INFUSING IN THE UAC BLOOD WAS NOTED TO BE BACKING UP IN THE CATHETER. FOUND TINY LEAK IN THE THINNEST PART WHERE CATHETER IS JOINED TO THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586749 UMBILI-CATH UMBILICAL ARTERY CATHETER FOS UTAH MEDICAL PRODUCTS, INC. 1142742

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR