BEUDAMED
    FDA Adverse Event Other Summary report: N

    SINGLE LUMEN UMBILICAL CATHETER

    MDR report key: 1844930 · Received September 24, 2010

    Report

    Report Number
    1844930
    Event Type
    Other
    Date Received
    September 24, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING AN UMBILICAL VENOUS CATHETER (UVC) FROM THE UMBILICAL VEIN, THE CATHETER "SUDDENLY SNAPPED" OR TORE, AT THE 9 CM SITE, LEAVING ABOUT 1 AND 1/2 CM ABOVE THE UMBILICAL BASE. IT WAS IMMEDIATELY CLAMPED, TO PREVENT FURTHER MIGRATION INTO THE VASCULATURE. THE REMAINING (CLAMPED) CATHETER WAS REMOVED FROM THE PATIENT ABOUT AN HOUR LATER WHEN ADEQUATE COAGULATION HAD BEEN ASSURED, WITHOUT KNOWN INJURY TO THE PATIENT. THE ORIGINAL PACKAGING IS UNAVAILABLE FOR FURTHER IDENTIFICATION OF THE LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE LUMEN UMBILICAL CATHETER UVC FOS UTAH MEDICAL PRODUCTS 4175005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA Other