BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 6017113 · Received October 11, 2016

    Report

    Report Number
    3012307300-2016-00029
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 6, 2016
    Report Date
    May 11, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K042172
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEO® 90 INFUSION SET ADHESIVE HAD ISSUES AND CAUSED THE CANNULA TO BECOME DISLODGED AND BENT. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE ADVERSELY AFFECTED AND REPORTED AT GREATER THAN 399MG/DL. THE PATIENT CHANGED THE SITE AND DELIVERED CORRECTION BOLUS OR ADMINISTERED AN INJECTION TO ADDRESS THE HIGH BLOOD GLUCOSE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2016-00016, 3012307300-2016-00017, 3012307300-2016-00028, 3012307300-2016-00030, 3012307300-2016-00031, 3012307300-2016-00032, 3012307300-2016-00033, 3012307300-2016-00034, 3012307300-2016-00035, 3012307300-2016-00036, 3012307300-2016-00037, 3012307300-2016-00038, 3012307300-2016-00039, 3012307300-2016-00040, 3012307300-2016-00041, 3012307300-2016-00042, 3012307300-2016-00043, 3012307300-2016-00044, AND 3012307300-2016-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668181 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention