BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 1140227 · Received August 29, 2008

    Report

    Report Number
    2183502-2008-00250
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FPA
    Adverse Event
    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 MFR FOR DEVICE EVAL. 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 EVAL.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT HAD ELEVATED BLOOD GLUCOSE WHICH COULD NOT BE RESOLVED. THE INFUSION SITE WAS RED AND INDURATED. THE SET WAS REMOVED AND SITE WAS NOTED TO BE PURULENT, WHICH TESTED POSITIVE FOR STAPHYLOCOCCUS. THE PT WAS TREATED WITH ANTIBIOTICS FOR THE LOCALIZED INFECTION.

    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) 21-7220 003X78

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Required Intervention