BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 3843596 · Received May 23, 2014

    Report

    Report Number
    2183502-2014-00334
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    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. MANUFACTURER'S REFERENCE: (B)(4).

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED ON BEHALF OF HOME-CARE USER THAT DURING REMOVAL OF THE LISTED INFUSION SET AFTER 3 DAYS IN USE, THE CANNULA BROKE AWAY FROM THE INFUSION SET AND REMAINED UNDER THE USER'S SKIN. THE USER WAS TAKEN TO THE ER WHERE THE FRAGMENT WAS REMOVED. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309055 CLEO 90 INFUSION SET SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7230 73X079

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other