BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 4862530 · Received June 18, 2015

    Report

    Report Number
    2183502-2015-00420
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 17, 2015
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED ON BEHALF OF HOME-CARE USER THAT AFTER 4-DAYS IN USE, USER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND DECIDED TO EXCHANGE THE SET. AFTER REMOVAL OF THE SET, USER NOTICED THAT THE CLEAR PLASTIC CANNULA HAD BECOME DETACHED AND ASSUMED THAT THE CANNULA FRAGMENT HAD REMAINED IN HER SKIN. THE PLASTIC CANNULA WAS NOT LOCATED IN THE PT'S SKIN. NO ATTEMPT HAS BEEN MADE TO REMOVE THE FRAGMENT FROM THE PT'S SKIN. NO FURTHER ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397967 CLEO 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL 21-7220 74X210

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK