BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE RESERVIOR, 50ML

    MDR report key: 17948762 · Received October 16, 2023

    Report

    Report Number
    MW5146973
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    October 6, 2023
    Report Date
    October 12, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CADD CASSETTE (REF 21-7301-24 MANUFACTURER: SMITHS MEDICAL ASD) LEAKED WHEN PREPARING MORPHINE SOLUTION 50ML. IN THE BEGINNING IT LEAKED FROM THE INTERIOR BAG INTO THE CASSETTE. BUT UPON FLIPPING CASSETTE UPSIDE DOWN TO WITHDRAW VOLUME TO MEASURE WASTE IT LEAKED FROM THE CASSETTE ONTO THE FLOOR. IT HAS OCCURED TWICE THAT I AM AWARE OF. WE WERE ABLE TO SAVE ONE OF THE PACKAGES CONTAINING THE LOT/EXPIRATION (4390626 EXP 4-22-2028). THE OTHER LOT/EXPIRATION IS UNKNOWN. THIS COULD CAUSE PATIENT HARM IF THE LEAK WASN'T DETECTED WITHIN THE IV ROOM. IT COULD ALSO CAUSE INADVERTENT MEDICATION EXPOSURE TO STAFF OR PATIENTS. REFERENCE REPORT: MW5146972.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96768 CADD MEDICATION CASSETTE RESERVIOR, 50ML SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown