BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6086168 · Received November 8, 2016

    Report

    Report Number
    3012307300-2016-00274
    Event Type
    Injury
    Date Received
    November 8, 2016
    Report Date
    October 19, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEO® 90 INFUSION SET DETACHED DURING USE. THE PATIENT OBSERVED THIS EVENT WHEN SHE WENT TO CHANGE HER CLOTHING. THE PATIENT'S BLOOD SUGARS INCREASED BUT DID NOT GO ABOVE 600MG/DL. THE INFUSION SET WAS CHANGED AND A INSULIN WAS ADMINISTERED TO ADDRESS THE HIGH BLOOD SUGARS. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2016-00275, 3012307300-2016-00276, 3012307300-2016-00277, AND 3012307300-2016-00278.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736878 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention