BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUDGET MEDICAL - ICU MEDICAL

    MDR report key: 475473 · Received July 29, 2003

    Report

    Report Number
    MW1029162
    Event Type
    Injury
    Date Received
    July 29, 2003
    Date of Event
    June 27, 2003
    Report Date
    July 14, 2003
    Manufacturer
    BUDGET MEDICAL
    Product Code
    FKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USED T-CONNECTOR FOR AN ARTERIAL LINE ON A PT. T-CONNECTOR WAS FOUND TO HAVE A CLOT FORMATION. FURTHER DISCUSSION WITH PHYSICIAN INDICATED THAT STAFF HAVE BEEN USING T-CONNECTOR IN THIS MANNER (AS AN ARTERIAL LINE CONNECTOR) WHEN NEITHER THE PACKAGING NOR THE MANUFACTURER HAD INDICATED NOT TO USE THE DEVICE IN THIS MANNER. PHYSICIAN IS AFRAID A LESS EXPERIENCED MD WILL NOT NOTICE THE CLOTTING AND FLUSH THE LINE INTO AN ARTERY, EMBOLIZING A CLOT, POTENTIALLY CAUSING STROKE AND FOR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUDGET MEDICAL - ICU MEDICAL T-CONNECTOR PED WITH VALVE FKB BUDGET MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention