BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILI-CATH

    MDR report key: 7181717 · Received January 11, 2018

    Report

    Report Number
    7181717
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 23, 2017
    Report Date
    December 29, 2017
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALE INFANT DELIVERED AT 26WK/1DAY VIA VAGINAL DELIVERY W/ APGAR'S 2/6. UMBILICAL VENOUS CATHETER (UVC) AND UMBILICAL ARTERIAL CATHETER (UAC) BOTH PLACED AFTER DELIVERY. UVC WAS A 3.5 FR DOUBLE LUMEN. IT WAS SECURED WITH SUTURE BUT CM MARKING IS NOT PROVIDED TO THIS REPORTER AND NOT AVAILABLE IN PATIENT'S EMR. LATERAL X-RAY SHOWED THE UVC TO BE HIGH. THE UVC WAS THEN RETRACTED BY 0.5 CM PER MD ORDER. UAC REMOVED. DURING CARE, THE RN ASSESSED THE UMBILICUS AREA TO BE WET. THE NNP WAS CALLED TO THE BEDSIDE. IT WAS DETERMINED THAT THE CATHETER WAS LEAKING. THE UVC HAD REMAINED IN POSITION FROM THE PREVIOUS REPOSITIONING ON DAY 2. ACCORDING TO THE CARE RN, STAFF WERE UNABLE TO DETERMINE WHERE THE UVC WAS LEAKING. TUBING TO THE UVC HAD BEEN CHANGED 1 HR EARLIER AND NO LEAKING WAS NOTED AT THAT TIME. NO CLAMPS WERE IN USE THAT COULD HAVE CONTRIBUTED TO LEAKING. THE RN REPORTED THE UVC REMAINED SUTURED BUT DID NOT APPEAR EXCESSIVELY TIGHT. THE UVC WAS REMOVED PER NNP ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25094 UMBILI-CATH CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL PRODUCTS, INC. 4273505 11663555

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR THE PATIENT HAD A UAC IN PLACE UP UNTIL 1 DAY PRIO