BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED MICRO VOL.INLET, N/S

    MDR report key: 13933054 · Received March 28, 2022

    Report

    Report Number
    1416980-2022-01375
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER CITY(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5, D1, D4: CATALOGUE #, G1: MANUFACTURING FACILITY NAME AND ADDRESS, AND G4: 510K #. B5: THE AFFECTED PRODUCT IS ¿VENTED MICRO-VOLUME INLET¿, PREVIOUSLY SUBMITTED AS ¿500ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG¿. D1: BRAND NAME: THE CORRECT BRAND NAME IS ¿VENTED MICRO VOL.INLET, N/S¿, PREVIOUSLY SUBMITTED AS ¿EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP¿ D4: CATALOGUE: THE CORRECT CATALOGUE # IS ¿H938175¿, PREVIOUSLY SUBMITTED AS ¿H938738¿. G1: CORRECTION TO MANUFACTURING FACILITY NAME AND ADDRESS. G4: 510K #: THE CORRECT # IS ¿K002705¿, PREVIOUSLY SUBMITTED AS ¿K900585¿. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. UNAIDED VISUAL INSPECTION WAS PERFORMED WHICH DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED AND NO LEAK WAS OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 500ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25888 VENTED MICRO VOL.INLET, N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown