BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 23498219 · Received November 7, 2025

    Report

    Report Number
    3012307300-2025-12224
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 7, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027192
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4 LOT#: POSSIBLE LOT NUMBERS 6092860, 6116309, 6116313. H3: NO PRODUCT WAS RETURNED BUT ONE VIDEO AND ONE PHOTO WERE ATTACHED TO THE COMPLAINT. IN THE VIDEO AND PHOTO, A PARTICLE WAS DETECTED IN THE FLUID PATH. ACCORDING TO VIDEO AND PHOTO RECEIVED, THE FAILURE MODE ¿A0226 - PARTICULATE INSIDE THE FLUID PATH¿ WAS CONFIRMED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRODUCTION USING THE 100 ML YELLOW CADD CASSETTES (PN 21-7300-24), A 100% VISUAL INSPECTION IDENTIFIED TWO CASSETTES WITH PARTICLES. THE MAJORITY OF THE CASSETTES USED WERE FROM LOT #6092860; HOWEVER, SINCE UNITS FROM OTHER LOTS WERE ALSO USED, IT IS NOT POSSIBLE TO SPECIFY A SINGLE LOT. LOT #6092860 HAS ALREADY BEEN FILED UNDER A PREVIOUS COMPLAINT ((B)(4)), AND LOT #6116309 HAS ALSO BEEN FILED UNDER A PREVIOUS COMPLAINT ((B)(4)). THESE CASSETTES ARE USED BY INTEGRADOSE FOR THE DELIVERY OF THE CONTROLLED SUBSTANCES FENTANYL CITRATE AND ROPIVACAINE HCL; THEREFORE, WE ARE UNABLE TO RETURN THE PRODUCT. THE PARTICLE APPEARS SIMILAR TO THOSE PREVIOUSLY OBSERVED AT INTEGRADOSE. SAMPLE PHOTO AND VIDEO WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186560 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 7300 NI 10610586027192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown