BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEO® 90 INFUSION SET

    MDR report key: 5843855 · Received August 3, 2016

    Report

    Report Number
    2183502-2016-01664
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 9, 2016
    Report Date
    July 13, 2016
    Manufacturer
    SMITHS MEDICAL
    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 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.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED ON BEHALF OF HOME-CARE PATIENT THAT THE INFUSION SET FELL OFF. THE PATIENT'S BLOOD GLUCOSE WAS NOT AFFECTED. NO DAMAGE TO THE PACKAGING WAS NOTICED UPON OPENING OF THE PACKAGE AT THE TIME. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495094 CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR