BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6140804 · Received December 2, 2016

    Report

    Report Number
    3012307300-2016-00424
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    July 10, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVOLVED LOT NUMBERS REPORTED BY CUSTOMER: 76X072, 75X079, AND 76X114 . POSSIBLE EXPIRATION DATE: 04/28/2021, 04/28/2020, 07/28/2016. POSSIBLE DEVICE MANUFACTURER'S DATE: 05/05/2016, 04/20/2015, 07/20/2016 . CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. MFR# CLARIFICATION: NEW REGISTRATION NUMBER (B)(4) ((B)(4)) IS NOW BEING USED FOR MFR REPORT NUMBER, REPLACING REGISTRATION NUMBER (B)(4) ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEO® 90 INFUSION SET CANNULA FELL OFF OR FAILED TO STICK PROPERLY. IT WAS NOTED THAT THE INFUSION SET FELL OFF IMMEDIATELY OR AFTER AN HOUR. THE CANNULA MAY HAVE SLID OVER WHILE THE TAPE WAS IN PLACE. THE PATIENT'S BLOOD GLUCOSE WAS KNOWN TO RISE. THE BLOOD GLUCOSE WAS BROUGHT DOWN BY REPLACING THE INFUSION SET AND ADMINISTERING A MANUAL SHOT. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2016-00409, 3012307300-2016-00410, 3012307300-2016-00411, 3012307300-2016-00412, 3012307300-2016-00413, 3012307300-2016-00414, 3012307300-2016-00415, 3012307300-2016-00416, 3012307300-2016-00417, 3012307300-2016-00418, 3012307300-2016-00419, 3012307300-2016-00420, 3012307300-2016-00421, 3012307300-2016-00422, 3012307300-2016-00423, 3012307300-2016-00425, 3012307300-2016-00426, 3012307300-2016-00427, 3012307300-2016-00428, 3012307300-2016-00429, 3012307300-2016-00430, AND 3012307300-2016-00431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793082 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention T-SLIM PUMP