BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMED

    MDR report key: 785500 · Received June 16, 2006

    Report

    Report Number
    MW1041029
    Event Type
    Injury
    Date Received
    June 16, 2006
    Date of Event
    June 13, 2006
    Report Date
    June 16, 2006
    Manufacturer
    IMED CORPORATION
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FREE FLOW PROTECTIVE DEVICE FAILED. BOLUS OF NTG DELIVERED TO PATIENT ON REMOVAL OF THE TUBING FROM IV PUMP. SEAR, MACHINED, EXTENDED, PART NUMBER 20-2279-8 BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMED GEMINI PC-2TI FRN IMED CORPORATION 1325 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening