BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 1912715 · Received November 17, 2010

    Report

    Report Number
    1718873-2010-00016
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    April 20, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 BELIEVE THIS USER MALFUNCTION IS NOT LIKELY TO RESULT IN A SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT CONSEQUENCE IF IT WERE TO RECUR. CONCLUSIONS: INSUFFICIENT MATERIAL RETURNED FOR TENSILE STRENGTH TEST. TUBING DAMAGED (CUT) NEAR SEVER.

    Description of Event or Problem · 1

    THE UMBILICAL CATHETER SNAPPED AT THE POINT OF ENTRY INTO THE BABY'S UMBILICUS. THE CATHETER WAS REMOVED FROM THE PATIENT WITHOUT SURGICAL INTERVENTION. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILI-CATH UMBILICAL CATHETER FOS UTAH MEDICAL PRODUCTS, INC. NA 1090401

    Patients

    Seq Age Sex Outcome Treatment
    1