BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 5758158 · Received June 29, 2016

    Report

    Report Number
    5758158
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    February 7, 2016
    Report Date
    May 24, 2016
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS CALLED TO THE BEDSIDE AS THE CHARGE RN TO LOOK AT A UAC THAT WAS LEAKING FROM THE UMBILICUS. AFTER FLUSHING THE LINE AGAIN AND WITNESSING THE LEAKING, I CALLED THE DR TO TROUBLESHOOT THE UAC. AFTER FLUSHING THE LINE, HE TRIED TO GENTLY PULL THE LINE OUT A LITTLE BIT AND IT SNAPPED IN HALF. WE IMMEDIATELY TRIED TO RETRIEVE THE BROKEN CATHETER WITH HEMOSTATS BUT HE WAS UNABLE TO GRASP IT AND PULLED BACK INTO THE VESSEL WHERE IT WAS UNABLE TO BE VISUALIZED. WE NOTIFIED THE DR OF THE BROKEN CATHETER AND HE ORDERED AN X-RAY TO VIEW THE LOCATION OF THE CATHETER AND CAME TO THE BEDSIDE. HE DID AN EMERGENCY CUTDOWN OF THE UMBILICUS AND REMOVAL OF THE CATHETER. HE WAS ABLE TO REMOVE THE 11CM OF CATHETER FROM THE BABY INTACT. THE BABY REMAINED STABLE THROUGHOUT THE NEXT SHIFT. THERE WERE NO COMPLICATIONS. UMBILICAL INCISION INTACT WITHOUT REDNESS OR DRAINAGE. UMBILICAL CATHETER 3.5 LOT # 1152069.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414847 UMBILI-CATH CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL PRODUCTS, INC. 3.5 1152069

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other