BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 2121447 · Received May 6, 2011

    Report

    Report Number
    2183502-2011-00389
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 3, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT THE CANNULA OF THE INFUSION SET MAY HAVE BECOME DETACHED FROM THE BASE AND MAY HAVE BEEN LOST WITHIN THE BODY. THE REPORTER STATED THAT THE CANNULA ALSO MAY HAVE BECOME BENT/FOLDED OVER AND ADHERED TO THE OCCLUSIVE DRESSING RATHER THAN PENETRATING THE BODY DURING THE SITE CHANGE. THE REPORTERS EYE SITE IS SO POOR THEY WERE UNABLE TO CONFIRM OR DENY THAT THE CANNULA WAS STILL IN THE PT'S SKIN OR CANNULA WAS STILL ATTACHED BUT FOLDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEO 90 INFUSION SET FPA - SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7230 061X70

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK