BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 3862973 · Received June 4, 2014

    Report

    Report Number
    2183502-2014-00367
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR COMPLETED THE ENTIRE FORM. ADDITIONAL MFR NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT DURING USE OF THE LISTED DEVICE, THE USER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. WHILE INSPECTING THE PUMP AND INFUSION SET FOR ISSUES THE USER FOUND THE CANNULA OF THE INFUSION SET WAS KINKED. THE INFUSION SET WAS REPLACED AND PT WAS SCHEDULED FOR HOSP RELEASE. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326804 CLEO 90 INFUSION SET SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7220 74X022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization