BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 23407968 · Received October 28, 2025

    Report

    Report Number
    3012307300-2025-11862
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ICU MEDICAL 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
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT NUMBERS 6070588 AND 6092860. H3: ONE PHOTO AND TWO VIDEOS WERE ATTACHED TO THE COMPLAINT. IN THE VIDEOS AND PHOTOS, A PARTICULATE WAS DETECTED INSIDE OF THE FLUID PATH. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED THROUGH THE MATERIALS PROVIDED. A LOT HISTORY REVIEW WAS PERFORMED AND NO NONCONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASSETTE CONTAINED PARTICLES, DESCRIBED AS OPAQUE, SLIVER/CRESCENT SHAPED IN APPEARANCE AND MOST LIKELY PLASTIC IN NATURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905634 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL MANUFACTURING S.A. DE C.V. UNKNOWN 10610586027192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FENTANYL CITRATE| ROPIVACAINE HCL