BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA

    MDR report key: 25325863 · Received May 28, 2026

    Report

    Report Number
    1416980-2026-01818
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    November 15, 2025
    Report Date
    May 28, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    UDI-DI
    00085412000046
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT (8) 1000ML INTRAVIA CONTAINERS HAD PARTICLES INSIDE THE BAGS. THE PARTICLES WERE DESCRIBED AS "WHITE FILAMENT" AND WERE FLOATING. THIS WAS OBSERVED DURING THE "ILP" PROCESS, 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
    432682 INTRAVIA CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION 2B8014 DR25G28024 00085412000046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown