BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK

    MDR report key: 24456179 · Received February 26, 2026

    Report

    Report Number
    9617594-2026-00200
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 31, 2026
    Report Date
    February 26, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709122437
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW COULD NOT BE REVIEWED DUE TO THE UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    EVENT OCCURRED REGARDING 122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK WHERE IT WAS STATED IN THE REPORT THAT THERE WAS LEAKING AT THE CONNECTION SITE OF BONDED CLAVE. EPINEPHRINE DRIP WAS FOUND TO BE LEAKING AT A CLEAR BLUE CAP THAT IS SEALED BY THE MANUFACTURER ONTO THE LONG DRIP LINES. THERE WAS NO FLUID ACCUMULATION ON THE SYRINGE PUMP. SYRINGE WAS NEARLY EMPTY, AND THE NEW EPINEPHRINE SYRINGE WAS AT BEDSIDE. NEW LONG DRIP LINE PRIMED AND IMMEDIATELY STARTED DOUBLE RUNNING. PATIENT REQUIRED INCREASE IN EPI DRIP, INCREASE IN CALCIUM DRIP AND A FLUID BOLUS. THERE WERE PATIENT INVOLVEMENT AND NO SERIOUS INJURY TO THE PATIENT, BUT IT REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514166 122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 00887709122437

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CALCIUM DRIP, MFR UNKNOWN| EPINEPHRINE DRIP, MFR UNKNOWN| FLUID BOLUS, MFR UNKNOWN.