BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 6MM X 24" INFUSION SET

    MDR report key: 6200219 · Received December 22, 2016

    Report

    Report Number
    3012307300-2016-00578
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 29, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND 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 THE 6MM X 24 INCH CLEO INFUSION SET DEVICE HAD ONLY 1MM CANNULA LENGTH REMAINING WHEN THE PATIENT WAS CHANGING OUT THE SITE DUE TO HYPERGLYCEMIA. IT WAS REPORTED THAT "NOTHING WAS SET AFTER HYPERGLYCEMIA, THE PATIENT FOLLOWED THE HABITUAL TREATMENT". NO FURTHER ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MFR: 3012307300-2016-00576, 3012307300-2016-00577.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849926 CLEO 6MM X 24" INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 76X063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other