BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24400656 · Received February 20, 2026

    Report

    Report Number
    3012307300-2026-01527
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    January 9, 2026
    Report Date
    February 20, 2026
    Manufacturer
    ICU MEDICAL MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30610586028339
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE REPORTING BECOME AWARE DATE AND G3 - DATE RECEIVED BY MFR SUBMITTED ON INITIAL REPORT REFERENCE NUMBER 3012307300-2026-01527-00 WAS 14-JAN-2026 H3 AND H6. CODES: UPDATED. DEVICE EVALUATION: RECEIVED ONE (1) USED CADD CLEO INFUSION SET. AS RECEIVED THE CANULA ON THE BASE WAS OBSERVED TO BE BENT AT 90 DEGREES. THE COMPLAINT OF BENT CANULA CAN BE CONFIRMED. THE PROBABLE CAUSE IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA WAS BENT AND HAD CAUSED TO GO HIGH ABOVE 400 MG PER DL. THE PERSON WITH DIABETES HAD SINCE CHANGED OUT THE SET AND RESUMED INSULIN. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460167 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL MANUFACTURING S.A. DE C.V. UNKNOWN 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female