BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK

    MDR report key: 24349344 · Received February 16, 2026

    Report

    Report Number
    9617594-2026-00147
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    June 1, 2025
    Report Date
    May 8, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709125766
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT OF LEAKS ON ITEM MC100 CANNOT BE CONFIRMED. SINCE 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 PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) REVIEW COULDN'T BE PERFORMED DUE TO THE LOT NUMBER FOR THIS COMPLAINT WAS UNKNOWN. D9 - DEVICE AVAILABLE FOR EVALUATION: NO.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION, HOWEVER, IT IS UNKNOWN IF IT WILL BE RETURNED; A DEVICE HISTORY REVIEW WILL BE PERFORMED. ADDITIONAL RELATED REPORT NUMBERS: 9617594-2025-01865-00; 9617594-2025-01810-00; 9617594-2025-01944-00; 9617594-2026-00116-00; 9617594-2026-00125-00.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED VIA A USER FACILITY MANDATORY MEDWATCH REPORT NUMBER (B)(4). THE DATE OF THE EVENT WAS AN UNKNOWN DATE IN JUNE 2025 AND INVOLVED A 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK, 0.2 MICRON FILTER, SPIN LUER WHERE THE CUSTOMER REPORTED THAT SMALL AIR BUBBLES IN TUBING. IT WAS REPORTED THAT THE NURSE WAS PRIMING NEONATAL INTENSIVE CARE UNIT (NICU) SPECIFIC DRIP TUBING FOR NEW MORPHINE GTT; THE NURSE HAD CONNECTED TUBING TO PORT ON UMBILICAL VENOUS CATHETER (UVC) WITH A BLUE CLAMP, AND THEN NOTICED SOME SMALL AIR BUBBLES STILL IN TUBING. THE NURSE WENT TO DISCONNECT FROM THE UVC PORT TO RE-PRIME TUBING AND WHEN ATTEMPTING TO DISCONNECT, THE TOP PIECE OF THE LUER LOCK OF THE DRIP TUBING SNAPPED OFF, LEAVING THE INTERNAL PIECE OF THE LUER LOCK CONNECTED TO THE UVC. THE NURSE HAD DIFFICULTY ATTEMPTING TO UNSCREW THE INTERNAL PORTION; THE NEONATAL NURSE PRACTITIONER (NNP) WAS SUCCESSFUL AT UNSCREWING. MORPHINE GTT WAS THEN PRIMED USING REGULAR MED TUBING AND FILTER AS THERE HAD BEEN ONGOING REPORTS OF ISSUES WITH THE DRIP TUBING. THERE WAS PATIENT INVOLVEMENT (INFANT,) BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532353 60" (152 CM) APPX 2.2 ML, EXT SET, SMALLBORE W/CLAVE¿ CLEAR, NANOCLAVE¿ STOPCOCK STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14113540 00887709125766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MORPHINE.