BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK

    MDR report key: 22719522 · Received August 5, 2025

    Report

    Report Number
    9617594-2025-01621
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 19, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709002937
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, TESTING HAS NOT YET BEEN COMPLETED. ADDITIONAL CONTACT: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY. RECEIVED ONE (1) USED. LIST #UNKNOWN, MICROCLAVE EXTENSION SET WITH MICRON FILTER; LOT #UNKNOWN. ONE (1) USED. LIST #B2020, 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK; LOT #UNKNOWN. --> ONE (1) USED. REF # (B)(4), 0.9% SODIUM CHLORIDE INJECTION, USP SINGLE USE 10 ML SYRINGE; LOT #5062449. A CRACK WAS OBSERVED ON THE FEMALE LUER OF THE TRANSFER SET. THE REPORTED COMPLAINT OF A CRACK COULD BE CONFIRMED. THE RETURNED EXTENSION SET WAS OBSERVED TO HAVE A CRACK ON THE FEMALE LUER. THE PROBABLE CAUSE IS DUE TO A MATERIAL ISSUE ON A VENDOR SUPPLIED PART. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. CORRECTIVE AND PREVENTATIVE ACTIONS ARE IN PROCESS.

    Description of Event or Problem · 0

    THE COMPLAINT INVOLVED A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK DEVICE. A SMALL COLLECTION OF FLUID WAS REPORTED ON THE SYRINGE PUMP BELOW THE CONNECTION FROM THE SYRINGE TO THE TUBING. THE PUMP WAS NOTED TO FEEL WET ON THE BOTTOM. ALSO, THEY NOTED A SMALL COLLECTION OF FLUID ON THE FLOOR BELOW THE IV POLE. THE STAFF ASSUMED IT WAS CAUSED FROM A LOOSE CONNECTION; AND THE TUBING WAS CHANGED WITH A NEW SYRINGE. THE STAFF TESTED THE CONNECTION BY FLUSHING THE PORT WITH SALINE AND NOTED TO BE A CRACK/LEAK NOTED ON THE IV TUBING BELOW THE CLAVE. THERE WAS UNEXPECTED OR PROLONGED CARE. THE REPORT STATED THAT THE STAFF WENT INTO ROOM TO CHANGE THE EMPTY DEXMEDETOMIDINE SYRINGE. THE TUBING WAS ATTACHED TO A MICROCLAVE AND 10 ML PREFILLED SALINE SYRINGE THESE ITEMS WILL BE RETURNED FOR EVALUATION. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2642423 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00887709002937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEXMEDITOMIDINE SYRINGE, MFR UNK.| IV POLE, MFR UNK.| UNSPECIFIED SYRINGE PUMP, MFR UNK.