BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1883747 · Received October 11, 2010

    Report

    Report Number
    1883747
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    UTAH MEDICAL
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    A 3.5 UMBILICAL LINE PLACED AND FLUID DROP NOTED AT THE 15 CM MARK. LINE BACKING UP AND HAD TO BE REPLACED. NO SUTURE NEAR AREA OF LEAK. LOT NUMBERS OF UMBILICAL LINES ON UNIT INCLUDED IN REPORT. PHYSICIAN STATED LINE LOOKED LIKE IT WAS FRAYING. UAC REPLACED WITHOUT INCIDENT. THE PRODUCT WAS SHIPPED BACK TO THE REP. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, UMBILICAL ARTERY FOS UTAH MEDICAL 4173505 1100477/ 1101120/ 1101553

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WK