BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY LIFECARE CONTAINER 100 ML SIZE

    MDR report key: 24437587 · Received February 24, 2026

    Report

    Report Number
    9615050-2026-00126
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 1, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    KPE
    UDI-DI
    10887787006831
    PMA / PMN Number
    K771228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED FIVE (5) USED. LIST #079510471, EMPTY LIFECARE CONTAINER 100 ML SIZE AND THREE (3) OPENED/UNUSED. LIST #079510471, EMPTY LIFECARE CONTAINER 100 ML SIZE. AS RECEIVED, NO DAMAGE OR ANOMALIES NOTED. THE BAGS WERE EXAMINED UNDER BRIGHT LIGHT AND NO EVIDENCE OF PARTICULATES WAS OBSERVED. RECEIVED FIFTEEN (15) PHOTOS FROM THE CUSTOMER OF VARIOUS BAGS WITH POSSIBLE PARTICULATES CIRCLED BY THE CUSTOMER WITH WRITTEN DESCRIPTIONS. THE THREE (3) EMPTY BAGS WERE FILLED WITH STERILE WATER USING ICU MEDICAL PROVIDED MATERIALS WHICH INCLUDED A PLUM SET, A STERILE WATER BAG, A CH-10, AND A SPIROS TO REPLICATE THE BAGS BEING FULL TO CHECK FOR PARTICULATES. UNDER BRIGHT LIGHTS NO PARTICULATES WERE OBSERVED. THE FLUID FROM THE EIGHT (8) TOTAL BAGS WAS FLUSHED AND COLLECTED IN A VACUUM FILTRATION SYSTEM. THE FILTER PAPER WAS EXAMINED UNDER A MICROSCOPE AT 10X MAGNIFICATION TO CHECK FOR PARTICULATES FROM THE BAG AND FLUID. THERE WERE NO RESIDUAL PARTICLES ON THE FILTER PAPER ON EIGHT (8) BAGS. THE SAMPLES WERE SENT TO AUSTIN FOR FTIR (FOURIER TRANSFORM INFRARED) ANALYSIS. THE ANALYSIS SHOWED THAT PARTICULATE MATTER WAS PRESENT ON THE FILTER PAPER WHEN OBSERVED UNDER HIGHER MAGNIFICATION. THE PARTICULATE MATTER OBSERVED WERE COMPOSED OF CELLULOSE AND OLEAMIDE. THE COMPLAINT OF PARTICULATE MATTER CAN BE CONFIRMED. PARTICULATE MATTER IDENTIFIED DURING THE INVESTIGATION WAS CONSISTENT WITH CELLULOSE-BASED FIBERS AND OLEAMIDE MATERIALS COMMONLY ASSOCIATED WITH PACKAGING AND POLYMER PROCESSING AIDS. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE SOURCE IS RELATED TO ENVIRONMENTAL OR MATERIAL HANDLING FACTORS RATHER THAN A SPECIFIC MANUFACTURING DEFECT. THE COSTA RICA AND AUSTIN TEAMS IMPLEMENTED PROCESS ENHANCEMENTS AND INSPECTION IMPROVEMENTS TO FURTHER REDUCE THE POTENTIAL FOR PARTICULATE INTRODUCTION. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT - THE DATE OF EVENT IS UNKNOWN, AND (B)(6) 2026 HAS BEEN USED AS A PLACEHOLDER. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS PENDING COMPLETION.

    Description of Event or Problem · 0

    EVENT OCCURRED REGARDING AN EMPTY LIFECARE CONTAINER 100 ML SIZE WHERE THEY REPORTED THAT THEY HAVE BEEN SEEING FIBER LIKE MATERIAL FLOATING IN POST-PRODUCTION PRODUCT. PREMIXED DRUGS THEY ARE MANUFACTURING - FENTANYL, KETAMINE, HYDROMORPHONE. THEY HAVE NOT HAD ANY INCIDENTS WITH PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612901 EMPTY LIFECARE CONTAINER 100 ML SIZE CONTAINER, I.V. KPE ICU MEDICAL COSTA RICA LTD. 14482697 10887787006831

    Patients

    Seq Age Sex Outcome Treatment
    1