BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER

    MDR report key: 23799907 · Received December 14, 2025

    Report

    Report Number
    9617594-2025-02303
    Event Type
    Malfunction
    Date Received
    December 14, 2025
    Date of Event
    October 15, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709001190
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF AIR IN LINE COULD NOT BE CONFIRMED. WITHOUT THE RETURN OF THE SAMPLE OR A PHOTO/VIDEO A COMPREHENSIVE REVIEW CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. THE LOT HISTORY WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION HOWEVER A DEVICE HISTORY REVIEW SHOULD BE PERFORMED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL CONTACT INFORMATION: (B)(4).

    Description of Event or Problem · 0

    THE EVENT INVOLVED AN 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER AND IT WAS REPORTED THAT PATIENT RECEIVING VENOFER INFUSION USING PORTLESS LINE REQUIRING HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT) FILTER. THREE HHT FILTERS WERE ATTEMPTED TO BE USED WITH THIS PATIENT. AIR BUBBLES CONTINUED TO KEEP APPEARING FROM HHT FILTER ATTACHMENT. HHT FILTER WITH A DIFFERENT LOT WAS USED AND WORKS WELL WITH NO AIR BUBBLES. THERE WERE NO PATIENT HARM AND MINIMAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325285 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14134684 00887709001190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT) FILTER| VENOFER, UNK MFR