BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 23091839 · Received September 18, 2025

    Report

    Report Number
    3012307300-2025-10827
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 1, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. D4 - CATALOG: POSSIBLE # 21-9301-24. H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT OF WATER DROPLETS INSIDE CASSETTE CANNOT BE REPLICATED OR CONFIRMED. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. RESERVOIR. CASSETTE, CADD, 50ML, RECEIVED NO DAMAGE OR ANOMALIES WERE OBSERVED. IN ATTEMPTS TO REPLICATE CLINICAL USE THE CASSETTE WAS FILLED WITH 50ML OF WATER USING AN ICU MEDICAL PROVIDED SYRINGE. NO LEAKAGE OR ISSUES FILLING WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WATER DROPLETS WERE FOUND INSIDE THE CASSETTE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868208 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6054016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown