BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPTY LIFECARE CONTAINER 100 ML SIZE

    MDR report key: 24407679 · Received February 20, 2026

    Report

    Report Number
    9615050-2026-00116
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED THREE OPENED/UNUSED. LIST #079510470, 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 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 THREE 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 THREE SETS. THE SAMPLES WERE SENT TO AUSTIN FOR AN FTIR 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 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. CORRECTED INFORMATION CAN BE FOUND IN B5, SECTION D10 CONCOMITANT PRODUCT, D4 - CATALOG # AND D4 - PRIMARY UDI NUMBER.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN H2 - IF FOLLOW-UP, WHAT TYPE?.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED INTERACTION NUMBER (B)(6). IT IS UNCLEAR WHAT THIS NUMBER IS. B3 - DATE OF EVENT - THE DATE OF EVENT IS UNKNOWN, AND 01 JAN 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

    ON AN UNSPECIFIED DATE, WITH KETAMINE BATCH 51161 AND 50958, PARTICULATE MATTER WAS IDENTIFIED IN THE EMPTY LIFECARE CONTAINER 100 ML SIZE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. THIS EMDR REFLECTS ONE OF TWO OCCURRENCES.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 51161) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196030 EMPTY LIFECARE CONTAINER 100 ML SIZE CONTAINER, I.V. KPE ICU MEDICAL COSTA RICA LTD. 14512283 10887787006831

    Patients

    Seq Age Sex Outcome Treatment
    1