BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVOIR

    MDR report key: 22629168 · Received July 28, 2025

    Report

    Report Number
    3012307300-2025-08965
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 28, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT NUMBERS 6085517, 6077788, 6054008, 6062720, 6054007. H3: ONE PHOTO WAS RECEIVED FOR EVALUATION. NO DEVICE HISTORY REVIEW COULD BE PERFORMED AS NO SPECIFIC LOT NUMBER WAS PROVIDED. A PARTICLE WAS SEEN IN THE PHOTO PROVIDED. THE COMPLAINT WAS CONFIRMED. THERE WAS NO KNOWN CAUSE OF THE ISSUE, AND NO FURTHER ACTION WAS TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PARTICLE WAS IDENTIFIED INSIDE THE BAG OF THE CASSETTE AFTER THE CASSETTE WAS FILLED. REPORTER STATED THAT IT WAS NOT POSSIBLE TO SPECIFY A SINGLE LOT NUMBER OF THE PRODUCT. REPORTER DESCRIBED THE PARTICLES AS, ¿A VERY SMALL SHRED OF PLASTIC.¿ THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610548 CADD MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown