BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 22843794 · Received August 19, 2025

    Report

    Report Number
    3012307300-2025-09784
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 19, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    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 NUMBERS 6070611, 6085525, 6037782. H3: NO PRODUCT WAS RETURNED BUT ONE PICTURE WAS RECEIVED AND REVIEWED. PARTICLES WERE OBSERVED INSIDE THE FILLING RESERVOIR. THE FAILURE MODE WAS CONFIRMED BASED ON THE PICTURE PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE EXACT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRODUCTION USING THE 100 ML GRAY CADD CASSETTES, A CASSETTE CONTAINING A PARTICLE HAD BEEN IDENTIFIED THROUGH 100% VISUAL INSPECTION. MOST CASSETTES USED WERE FROM LOT# 6070611; HOWEVER, UNITS FROM OTHER LOTS WERE USED SO IT WAS NOT POSSIBLE TO SPECIFY A SINGLE LOT. THE PARTICLES HAD BEEN DESCRIBED BY STAFF AS ¿WHITE/OPAQUE AND SLIGHTLY CURLY - SIMILAR TO WHAT THEY HAD OBSERVED BEFORE." SAMPLE PHOTO WAS PROVIDED. THE POSSIBLE LOT NUMBERS ARE 6070611, 6085525, 6037782.THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253231 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 7300 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown