BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 21600263 · Received March 13, 2025

    Report

    Report Number
    3012307300-2025-02860
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 13, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30610586028391
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 4142990 WERE REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DOES NOT DIFFUSE THE PRODUCT DUE TO OCCLUSION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700281 CLEO 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4142990 30610586028391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown