BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 1070351 · Received June 30, 2008

    Report

    Report Number
    2183502-2008-00168
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 27, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    LAY USER/PATIENT

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT THE CANNULA OF THE INFUSION SET BECAME DETACHED FROM THE BASE AND MAY HAVE BEEN LOST WITHIN THE BODY. THE REPORTER STATED THAT SHE PERFORMED A SITE CHANGE. WHEN REMOVING THE SET SHE FOUND THAT A PORTION OF THE CANNULA WAS NOT ATTACHED AND THOUGHT IT MAY HAVE BEEN LEFT UNDER THE SKIN. THE REPORTER COULD NOT CONFIRM OR DENY THAT THE CANULA WAS STILL IN THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEO 90 INFUSION SET SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL MD (FORMERLY DELTEC, INC.) 21-7231 007X78

    Patients

    Seq Age Sex Outcome Treatment
    1