BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6052192 · Received October 24, 2016

    Report

    Report Number
    3012307300-2016-00180
    Event Type
    Injury
    Date Received
    October 24, 2016
    Report Date
    May 11, 2018
    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 RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. MFR# CLARIFICATION: NEW REGISTRATION NUMBER 3012307300 ((B)(4)) IS NOW BEING USED FOR MFR REPORT NUMBER, REPLACING REGISTRATION NUMBER 2183502 ((B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEO 90 INFUSION SET FAILED DUE TO LACK OF ADHESIVE AROUND THE CANNULA OR THAT THE ADHESIVE WAS STUCK TOGETHER, WHICH DID NOT ALLOW THE PATIENT TO PROPERLY ADHERE THE SET TO HIS BODY. IT WAS NOTED THAT THE FAILURES HAD OCCURRED OVER THE PAST 60 DAYS FROM (B)(6) 2016. THE PATIENT'S BLOOD GLUCOSE WAS ADVERSELY AFFECTED AND REPORTED AT 355MG/DL. THE PATIENT CHANGED THE INFUSION SET AND CONTINUED USING HIS PUMP TO ADDRESS THE HIGH BLOOD GLUCOSE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2016-00168, 3012307300-2016-00169, 3012307300-2016-00170, 3012307300-2016-00171, 3012307300-2016-00172, 3012307300-2016-00173, 3012307300-2016-00174, 3012307300-2016-00175, 3012307300-2016-00176, 3012307300-2016-00177, 3012307300-2016-00178, 3012307300-2016-00179, AND 3012307300-2016-00181.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702491 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1