BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 1911417 · Received November 17, 2010

    Report

    Report Number
    1718873-2010-00013
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    March 18, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CATHETERS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THREE CATHETERS FROM THE SAME LOT NUMBER BROKE DURING USE. THERE WAS NO PATIENT IMPACT. ONE CATHETER BROKE NEAR THE LOCATION OF THE SUTURES AS THE CATHETER WAS BEING PULLED BACK. ONE CATHETER BROKE AT THE BASE OF THE Y SECTION OF THE OVERMOLDED HUB AS THE PATIENT WAS BEING MOVED. ONE CATHETER BROKE AN INCH ABOVE THE SUTURES AFTER 4-5 DAYS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILI-CATH UMBILICAL CATHETER FOS UTAH MEDICAL PRODUCTS, INC. NA 1092253

    Patients

    Seq Age Sex Outcome Treatment
    1