BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3924946 · Received July 3, 2014

    Report

    Report Number
    3924946
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 3, 2014
    Manufacturer
    B. BRAUN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    IV TUBING WAS CONNECTED TO PATIENT. THE DOCTOR WAS TRYING TO PUSH A PROPOFOL IV SYRINGE MEDICATION PRIOR TO INTUBATION AND REALIZED THAT IV ADMINISTRATION SET WAS KINKED. BECAUSE OF THE KINK, THE TUBING WAS NOT ALLOWING MEDICATION TO RUN IN DIRECTION OF PATIENT. UNABLE TO PUSH MEDICATION UNLESS TUBE WAS RELEASED MANUALLY AT THE KINK WHICH WAS AT THE END OF THE ONE WAY CONNECTION WITH TUBE. THE KINK CONTINUED TO BEND IN THE DIRECTION IT WAS PACKAGED BECAUSE OF THE MEMORY IN THE PLASTIC TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389207 * SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN 490002 0061358054

    Patients

    Seq Age Sex Outcome Treatment
    1 *