BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    NS 500 ML BAGS

    MDR report key: 16111808 · Received January 6, 2023

    Report

    Report Number
    16111808
    Event Type
    No answer provided
    Date Received
    January 6, 2023
    Date of Event
    November 15, 2022
    Report Date
    December 19, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PEDIATRIC PHARMACY STAFF NOTICED NS 500 ML IV BAG DO NOT HAVE BARCODES. MANUFACTURER RESPONSE FOR IV BAG, NS 500 ML BAGS (PER SITE REPORTER) [REDACTED DATE] PHARMACY STATED THEY WERE GOING TO ENTER AN RL. THIS WAS REPORTED TO MEDLINE ([REDACTED NAME]) AND BAXTER (PHARMACY). BAXTER (B)(4) [REDACTED DATE] [REDACTED NAME] REQUESTED BAXTER SEND ANOTHER RMA AS THEY HAD SENT THE ORIGINAL TO [REDACTED NAME] AT ANOTHER SITE. SHE PROVIDED BAXTER WITH THE ADDRESS FOR [REDACTED NAME] IN PHARMACY. NO OTHER BAGS EXCEPT THE ONES REPORTED IN THIS INCIDENT WERE FOUND TO BE AFFECTED, EVEN THOSE IN THE SAME LOT# 462375.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636000 NS 500 ML BAGS SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION 2B1323Q Y403641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown