BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXT SET 10" 5MIC

    MDR report key: 23768665 · Received December 10, 2025

    Report

    Report Number
    MW5180249
    Event Type
    Other
    Date Received
    December 10, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 4, 2025
    Manufacturer
    UNK
    Product Code
    FPB
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HOSPITAL PHARMACY FOUND THAT THE PATIENT HAS BEEN USING ARALAST WITH A 5-MICRON FILTER INSTEAD OF A 20-MICRON FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167840 EXT SET 10" 5MIC FILTER, INFUSION LINE FPB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female ARALAST NP.