BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 24756728 · Received April 1, 2026

    Report

    Report Number
    3012307300-2026-03170
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRODUCTION USING 100 ML GREY CADD CASSETTES, A 100% VISUAL INSPECTION AND SUBSEQUENT REINSPECTION IDENTIFIED THREE CASSETTES CONTAINING PARTICULATE MATTER. TWO LOTS WERE USED IN THIS PRODUCTION, 6171577 ((B)(4) UNITS) AND 6147681 ((B)(4) UNITS), AND NEITHER LOT HAD PREVIOUSLY BEEN ASSOCIATED WITH A FILED COMPLAINT. THE CASSETTES, USED BY INTEGRADOSE FOR DELIVERY OF HYDROMORPHONE HCL, WERE NOT AVAILABLE FOR RETURN; HOWEVER, PHOTOGRAPHS OF THE OBSERVED PARTICLES WERE PROVIDED. THE PARTICLES WERE DESCRIBED BY STAFF AS ONE SLIVER-SHAPED, ONE ROUND, AND ONE VERY SMALL PARTICLE, CONSISTENT WITH PARTICLE TYPES PREVIOUSLY OBSERVED AT INTEGRADOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812500 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 7302 UNCONFIRMED 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown