BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 21256620 · Received January 28, 2025

    Report

    Report Number
    3012307300-2025-01272
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 28, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GRAY PARTICLE WAS FLOATING IN THE SOLUTION OF THE CADD WHILE INSPECTING OVER THE WHITE BOARD. THERE WAS NO PATIENT INVOLVEMENT. THE POSSIBLE LOT NUMBERS ARE AS LISTED: 6022037, 6012479, 6012478, 6004936, 6022037, 4461359, 4390630, AND 4461358.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376202 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. UNKNOWN 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown