BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET, 9MM CANNULA, 24" TUBING

    MDR report key: 6100277 · Received November 14, 2016

    Report

    Report Number
    3012307300-2016-00325
    Event Type
    Injury
    Date Received
    November 14, 2016
    Report Date
    October 26, 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
    CA, US
    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. THE PATIENT REPORTED THAT THE 30 INCIDENTS REPORTED CAME FROM TWO DIFFERENT LOT NUMBERS. LOT NUMBER: 76X033, WITH A MANUFACTURE DATE OF FEBRUARY 29, 2016 AND AN EXPIRATION DATE OF FEBRUARY 28, 2021. LOT NUMBER 75X099, WITH A MANUFACTURE DATE OF MAY 27, 2015 AND AN EXPIRATION DATE OF MAY 28, 2020. MFR# CLARIFICATION: NEW REGISTRATION NUMBER (B)(4), ((B)(4)) IS NOW BEING USED FOR MFR REPORT NUMBER, REPLACING REGISTRATION NUMBER (B)(4), ((B)(4) ).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WITH THE CLEO 90 INFUSION SET ADHERING FOR THE PAST TWO YEARS. THE CUSTOMER REPORTED THAT THE PROBLEMS WITH THE ADHESION OF THE SITE WAS SPECIFICALLY THE ADHESIVE OF THE SITE FALLING OFF RIGHT AFTER THE CUSTOMER ATTEMPTED TO INSERT THE INFUSION SET. THE CUSTOMER WAS ADVISED BY CUSTOMER TECHNICAL SERVICES TO KEEP THE INSERTER CLOSE TO THE INFUSION SET AREA BEFORE INSERTING SINCE THE SITE IS HEAT ACTIVATED. THE PATIENT WAS ALSO ADVISED TO ROCK THE SITE BACK AND FORTH BEFORE PULLING APPLICATOR AWAY TO INCREASE THE EFFECTIVENESS OF THE ADHESION. THE PATIENT REPORTED BLOOD GLUCOSE LEVELS IN THE 300 MG/DL AND THAT NO KETONE LEVELS WERE TESTED. THE PATIENT WAS ABLE TO CORRECT THE HIGH BLOOD GLUCOSE LEVELS BY DELIVERING A CORRECTION BOLUS WITH THE PUMP. THE PATIENT STATED THAT THIS HAS HAPPENED TO 30 INFUSION SETS OVER THE STATED TIME PERIOD. NO FURTHER ADVERSE HEALTH OUTCOMES WERE REPORTED. SEE MFR: 3012307300-2016-00302 3012307300-2016-00303 3012307300-2016-00304 3012307300-2016-00305 3012307300-2016-00306 3012307300-2016-00307 3012307300-2016-00308 3012307300-2016-00309 3012307300-2016-00310 3012307300-2016-00311 3012307300-2016-00312 3012307300-2016-00313 3012307300-2016-00314 3012307300-2016-00315 3012307300-2016-00316 3012307300-2016-00317 3012307300-2016-00318 3012307300-2016-00319 3012307300-2016-00320 3012307300-2016-00321 3012307300-2016-00322 3012307300-2016-00323 3012307300-2016-00324 3012307300-2016-00326 3012307300-2016-00327 3012307300-2016-00328 3012307300-2016-00329 3012307300-2016-00330 3012307300-2016-00331.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750354 CLEO® 90 INFUSION SET, 9MM CANNULA, 24" TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention