BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 1911420 · Received November 17, 2010

    Report

    Report Number
    1718873-2010-00017
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    June 21, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON INVESTIGATION, THERE WAS NO EVIDENCE THAT THE EVENT WAS RELATED TO A DEVICE DEFECT. UTMD AND ITS INDEPENDENT EXPERT CLINICAL ADVISORS BELIEVES THIS USER MALFUNCTION IS NOT LIKELY TO RESULT IN A SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT CONSEQUENCE IF IT WERE TO RECUR. THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL.

    Description of Event or Problem · 1

    AN UMBILI-CATH BROKE DURING USE. THE CATHETER WAS ROUTINELY REMOVED AND WAS NOT REPLACED. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILI-CATH UMBILICAL CATHETTER FOS UTAH MEDICAL PRODUCTS, INC NA 110001 OR 1092513

    Patients

    Seq Age Sex Outcome Treatment
    1