BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED MICRO VOL.INLET, N/S

    MDR report key: 18314379 · Received December 12, 2023

    Report

    Report Number
    1416980-2023-06469
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 15, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    UDI-DI
    00085412475806
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D2A: COMMON DEVICE NAME: SET, I.V. FLUID TRANSFER (PREVIOUSLY SUBMITTED AS SYSTEM/DEVICE, PHARMACY COMPOUNDING). CORRECTION MADE TO D2B: CLASSIFICATION CODE: LHI (PREVIOUSLY SUBMITTED AS NEP). FIVE (5) DEVICES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND AN AREA OF BROWN SPOTS AT THE OUTER WALL OF THE WHITE MICRO CONNECTOR OF TWO SAMPLES WERE OBSERVED. NO DEFECTS WERE OBSERVED IN THE OTHER THREE SAMPLES. AN INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND VERIFIED EMBEDDED BROWN SPOTS IN AN AREA OF THE OUTER WALL INLET WHITE CONNECTOR OF THE TWO SAMPLES. THE REPORTED CONDITION WAS VERIFIED FOR TWO SAMPLES. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE (3) VENTED HIGH-VOLUME INLETS HAD GELATINOUS FOREIGN MATTER ON THE PRODUCT. THE FOREIGN MATTER WAS OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779097 VENTED MICRO VOL.INLET, N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 803481 00085412475806
    2240731 VENTED MICRO VOL.INLET, N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA 803481 00085412475806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown