BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 5360951 · Received January 7, 2016

    Report

    Report Number
    MW5059245
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    January 2, 2016
    Report Date
    January 7, 2016
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    (B)(6) MEDICAL PRODUCTS, UMBILI-CATH, LOT#1151435) WAS FOUND TO BE LEAKING AT SHIFT CHANGE. AS A RESULT, PT WAS NOT GETTING THE ENTIRE VOLUME OF FLUIDS, LINE WAS QUICKLY REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10443 UMBILI-CATH UMBILI-CATH FOS UTAH MEDICAL PRODUCTS 4275005 1151435

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other