BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    250 ML TPN BAG

    MDR report key: 11866992 · Received May 21, 2021

    Report

    Report Number
    1416980-2021-03105
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION WAS RECEIVED INFORMING THAT THE AFFECTED PRODUCT IS ¿250ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG¿, PREVIOUSLY REPORTED AS ¿NON-VENTED HIGH-VOLUME INLET¿. D1: THE CORRECT BRAND NAME IS ¿250 ML TPN BAG¿, PREVIOUSLY SUBMITTED AS ¿NON VENTED HIGH VOL.INLET,N/S¿. D4: CATALOGUE #: THE CORRECT CATALOGUE # IS ¿H938737¿, PREVIOUSLY SUBMITTED AS ¿H938173¿. D4: EXPIRATION DATE: THE EXPIRATION DATE IS ¿08/31/2023¿, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: UDI #: THE UDI # IS (B)(4), PREVIOUSLY SUBMITTED AS ¿NI¿. G1: DEVICE MANUFACTURERS INFORMATION: THE CORRECT DEVICE MANUFACTURERS INFORMATION IS ¿AVAILMED C. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND. TIJUANA, BAJA CALIFORNIA 22444, MEXICO¿, PREVIOUSLY SUBMITTED AS ¿PLASTICOS Y MATERIAS PRIMAS PYMPSA 3609-2 JUAN DE LA BARRERA PARQUE INDUSTRIAL EL ALAMO GUADALAJARA JALISCO 44490, MEXICO". G4: PMA/510K # OR BLA #: THE CORRECT 510K # IS ¿K900585¿, PREVIOUSLY SUBMITTED AS ¿K002705¿. H10: 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

    INITIAL REPORTER ADDRESS: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NON-VENTED HIGH-VOLUME INLET HAD AN UNSPECIFIED LEAK. THIS WAS NOTICED BEFORE USE, BEFORE TREATMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763375 250 ML TPN BAG SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 60260667

    Patients

    Seq Age Sex Outcome Treatment
    1