BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500 ML TPN BAG

    MDR report key: 8601429 · Received May 10, 2019

    Report

    Report Number
    1416980-2019-02645
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Report Date
    July 29, 2019
    Manufacturer
    BAXTER HEALTHCARE ¿ ROUND LAKE
    Product Code
    LHI
    UDI-DI
    00085412477220
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED BETWEEN OCTOBER 08, 2018 - OCTOBER 09, 20108. 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

    DATE OF EVENT: THE CUSTOMER STATED THIS "OCCURRED OVER THIS PAST WEEKEND" (NOT FURTHER SPECIFIED). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE (3) 500ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS WERE LEAKING FROM UNSPECIFIED LOCATIONS. THE LEAKS WERE DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395452 500 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE ¿ ROUND LAKE NA 60151659 00085412477220

    Patients

    Seq Age Sex Outcome Treatment
    1