BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿

    MDR report key: 23211140 · Received October 3, 2025

    Report

    Report Number
    9617594-2025-01946
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 12, 2025
    Report Date
    January 28, 2026
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: 12/18/2025. RECEIVED ONE (1) USED. LIST #011-A1214, EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿; LOT #14149724. ONE (1) USED. LIST #UNKNOWN, 5 ML B-D PLASTIPAK SYRINGE; LOT #UNKNOWN. A STICK DOWN WAS OBSERVED ON ONE OF THE MICROCLAVES AND OCCURRED UPON DECONTAMINATION. THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE RETURNED SAMPLE WAS OBSERVED TO HAVE A STICK DOWN AFTER DECONTAMINATION. THE SAMPLE WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED SPIKE. THE PROBABLE CAUSE IS FROM THE USE OF AN INCOMPATIBLE MATING DEVICE. THE DFU STATES: DO NOT USE DEAD END CAPS ON MICROCLAVES. THE LOT HISTORY WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    G4: MODEL NUMBER IS NOT SOLD IN THE US, BUT SIMILAR DEVICE IS SOLD UNDER MODEL K964435. THIS PRODUCT WAS USED FOR THE PRODUCT CODE, AND 501K. I SUGGEST A1064 FOR THE K964435. INVESTIGATION SUMMARY THE REPORTED COMPLAINT OF A LEAK 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.

    Description of Event or Problem · 0

    EVENT OCCURRED REGARDING AN EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE WHERE THE REPORTER STATED THE FOLLOWING: ¿DURING MY 6-HOUR MONITORING SESSION, I NOTICED THAT LIQUID WAS "DRIPPING" FROM THE UNUSED ONE-WAY VALVE OF THE "OCTOPUS". I INSTALLED A CAP ON THE VALVE AND THEN NOTICED THAT PRODUCT WAS STILL LEAKING FROM A PLASTIC WELD. THIS INCIDENT TOOK PLACE IN INFANT INTENSIVE CARE. THE EVENT OCCURRED DURING THE INFUSION. FOR SEVERAL HOURS, ONLY THE PARENTERAL NUTRITION BAG HAD BEEN ADMINISTERED, CONTINUOUSLY." THERE WERE NO ADVERSE EVENTS NOTED OR DELAYS IN THERAPY. THERE WAS NO NEED FOR MEDICAL INTERVENTION. THERE IS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235344 EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿ STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14149724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PARENTERAL NUTRITION BAG, UNKNOWN MGR.