BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 1911461 · Received November 17, 2010

    Report

    Report Number
    1718873-2010-00025
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    September 30, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC
    Product Code
    FOS
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 TENSILE STRENGTH AND ELASTICITY OF THE RETURNED CATHETER WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    UMBILI-CATH BROKE WHILE MOVING INFANT. THERE WAS NO PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1