BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORMAL SALINE

    MDR report key: 16724103 · Received April 12, 2023

    Report

    Report Number
    16724103
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    February 10, 2023
    Report Date
    February 21, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BAXTER NS LOT# G160629 (X3). BAXTER NS LOT# G160902 (X5). BAXTER NS LOT# G159647 (X1). BAXTER STERILE WATER LOT# G161022, G159609, G160360. B.BRAUN NS LOT# J2S947. POSSIBLE CONTAMINATES COMING OUT OF BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107706 NORMAL SALINE CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION G160629 (X3)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown