BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM BURETROL

    MDR report key: 4192301 · Received October 10, 2014

    Report

    Report Number
    4192301
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    BURETROL CRACKED WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643885 CLEARLINK SYSTEM BURETROL SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR