BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2000 ML TPN BAG

    MDR report key: 9078141 · Received September 17, 2019

    Report

    Report Number
    1416980-2019-05093
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Report Date
    October 17, 2019
    Manufacturer
    BAXTER HEALTHCARE ¿ ROUND LAKE
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED BETWEEN JANUARY 11, 2019 - JANUARY 12, 2109. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED BETWEEN (B)(6) 2019. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE MIDDLE PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869052 2000 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE ¿ ROUND LAKE NA 60165867

    Patients

    Seq Age Sex Outcome Treatment
    1