BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL-MATE

    MDR report key: 11200938 · Received January 20, 2021

    Report

    Report Number
    11200938
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 22, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BAXTER INTERNATIONAL INC. VIAL-MATE ADAPTORS WERE REPORTED AS DEFECTIVE AND WOULD NOT MIX. THE THREE LOTS WITH ISSUES ARE: P407429, US007336, US007260. MOST OF THE MALFUNCTIONING DEVICES ARE FROM LOT P407429.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97276 VIAL-MATE SET, I.V. FLUID TRANSFER LHI BAXTER INTERNATIONAL INC. P407429

    Patients

    Seq Age Sex Outcome Treatment
    1