BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 6085997 · Received November 8, 2016

    Report

    Report Number
    6085997
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 4, 2016
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEONATOLOGIST PULLED UVC AFTER REVIEWING PLACEMENT VIA X-RAY. NEONATOLOGIST NOTICED SMALL AMOUNT OF FLUID LEAKAGE AROUND UVC AT THE 13 CENTIMETER MARK. THE UVC WAS LEFT IN PLACE. ARTERIAL PRESSURE WAS WITHIN NORMAL LIMITS AND NO BLOOD WAS BACKING UP IN THE UVC. SUBSEQUENTLY, ARTERIAL PRESSURE COULD NOT BE OBTAINED, SO AN ATTEMPT WAS MADE TO DRAW BLOOD BACK AND FLUSH THE LINE. AIR WAS NOTED COMING INTO THE STOPCOCK. THE STOPCOCK WAS CLOSED OFF AND THE NEONATOLOGIST WAS INFORMED. THE NEONATOLOGIST DECIDED TO INSERT ANOTHER UVC. ONCE THE SECOND UVC WAS INSERTED, THE NEONATOLOGIST NOTED A LEAK WHERE THE DOUBLE LUMENS MEET. THE SECOND UVC WAS REMOVED AND REPLACED WITH A THIRD UVC. THE THIRD UVC DID NOT HAVE ANY LEAKS. NO UNTOWARD PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738530 UMBILI-CATH CATHETER, UMBILICAL FOS UTAH MEDICAL PRODUCTS, INC. 4273505 1161784

    Patients

    Seq Age Sex Outcome Treatment
    1