BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER

    MDR report key: 21327687 · Received February 6, 2025

    Report

    Report Number
    9617594-2025-00234
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    November 25, 2024
    Report Date
    February 6, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619099824
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4, G4: MODEL NUMBER IS NOT SOLD IN THE US BUT SIMILAR DEVICE IS SOLD UNDER MODEL SC9045. THIS PRODUCT WAS USED FOR THE PRODUCT CODE AND 501K. E1 - THIS COMPLAINT WAS RECEIVED THROUGH: ANA BOCCARDO LANGUAGE SCIENCE, INC. 101 STAN LANDING, SUITE 500 MEDFORD, MA 02155 T: 800.240.0246 F: 617.621.2552 [email protected] INVESTIGATION SUMMARY ONE (1) PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. THE PHOTOGRAPH CANNOT CONFIRM THE COMPLAINT OF LEAKING FROM THE OPENING OF FILTER WHEN IT WAS CONNECTED TO THE PATIENT THE DHR WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED FROM THE PHOTOGRAPH PROVIDED. THE DHR FOR LOT NUMBER 13918401 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED WITH REGARD TO A 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER THAT EXPERIENCED LEAKAGE DURING USE. THE REPORTER STATED THAT, "NO LEAKAGE WAS OBSERVED WHEN EXPELLING AIR FROM THE FILTER, BUT THE MEDICATION BEGAN LEAKING FROM THE OPENING OF FILTER WHEN IT WAS CONNECTED TO THE PATIENT TO START THE INFUSION. AS THE PRODUCT WAS ALREADY CONTAMINATED, IT WAS DISCARDED AS A DEFECTIVE ITEM AFTER BEING PHOTOGRAPHED." THERE WAS IV SOLUTION USED, BUT THE DRUG NAME WAS UNKNOWN. PICTURE IS PROVIDED SHOWING THE SAMPLE WITH RED MARK. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910118 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13918401 00840619099824

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown