BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD

    MDR report key: 11559596 · Received March 24, 2021

    Report

    Report Number
    11559596
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 19, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    UDI-DI
    10885403236259
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE END CONNECTOR OF THE CAREFUSION 303, INC. MAXGUARD EXTENSION SET BROKE OFF COMPLETELY FROM THE TUBING AFTER THE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456943 MAXGUARD SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. ME2020 19125802 10885403236259

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA