BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22341202 · Received June 26, 2025

    Report

    Report Number
    9617594-2025-01356
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 26, 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
    VA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) USED. LIST #B2020, 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK; LOT #14080229. ONE (1) USED. LIST #UNKNOWN, MICROCLAVE; LOT #UNKNOWN. A CRACK WAS OBSERVED ON THE FEMALE LUER. ONE (1) NEW. LIST #B2020, 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK; LOT #14080229. NO VISUAL DAMAGES OR ANOMALIES WERE OBSERVED ON THE NEW 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. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK WAS FOUND TO HAVE EXPERIENCED A LEAK DURING PATIENT USE. IT WAS REPORTED THAT THAT FLUID WAS DRIPPING TO THE FLOOR BY THE INTRAVENOUS (IV) POLE. UPON INVESTIGATION, MORPHINE WAS FOUND TO BE LEAKING FROM THE TUBING WHERE THE SMARTSITE CONNECTS TO THE TUBING. ADDITIONALLY, THERE WAS A CRACK IN THE TUBING. IT WAS ALSO MENTIONED THAT THE PATIENT HAD ABNORMAL VITALS (TEMPERATURE/HR, RR), WORK OF BREATHING, AND AGITATION EMESIS. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176612 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. 14080229 00887709002937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MORPHINE, UNK MFR.