BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO

    MDR report key: 23126170 · Received September 23, 2025

    Report

    Report Number
    9617594-2025-01886
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) OPENED/UNUSED AC236 ADMIN SET FOR INSPECTION. AS RECEIVED, THE BASEPLATE OF THE MANIFOLD WAS BROKEN OFF. EXAMINATION OF THE BASEPLATE AND MANIFOLD SHOWED SUFFICIENT SOLVENT COVERAGE. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE IS DUE TO AN EXTERNAL FORCE. IT IS UNKNOWN WHEN THE EXTERNAL FORCE OCCURRED. THE LOT HISTORY WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT - THE DATE OF EVENT IS UNKNOWN, AND (B)(6) 2025 HAS BEEN USED AS A PLACEHOLDER. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS PENDING COMPLETION.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING A NANOCLAVE STOPCOCK W/BASEPLATE, SPIN LUER, 2 EXT THAT EXPERIENCED BREAKAGE. IT WAS NOT REPORTED WHETHER THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE STOPCOCK PLATES BREAKING OFF ON THE OR IV SETS. NO DELAY OR HUMAN HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733001 132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14412441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown