BEUDAMED
    FDA Adverse Event Death Summary report: N

    UMBILICAL CATHETER

    MDR report key: 1190043 · Received September 6, 2008

    Report

    Report Number
    MW5008543
    Event Type
    Death
    Date Received
    September 6, 2008
    Date of Event
    August 30, 2008
    Report Date
    October 6, 2008
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INFANT TRANSFERRED TO OUR NICU. UMBILICAL VENOUS CATHETER -UVC- INSERTED AT RECEIVING FACILITY IN 2008. UVC WAS FOUND DISCONNECTED AT HUB ABOUT FIVE DAYS LATER. LARGE AMOUNT OF BLOOD FOUND IN INFANT'S BED. INFANT RECEIVED 2 TRANSFUSIONS. INFANT DIED AFTER UNDERGOING SURGERY FOR TREATMENT OF NECROTIZING ENTEROCOLITIS. CANNOT DETERMINE IF LOSS OF BLOOD THROUGH UVC CAUSED OR CONTRIBUTED TO INFANT'S DEMISE. NO AUTOPSY WAS PERFORMED. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: PREMATURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL CATHETER NONE FOS UTAH MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death