BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 2920150 · Received January 9, 2013

    Report

    Report Number
    2183502-2012-00666
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 8, 2013
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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

    IT WAS REPORTED BY A CUSTOMER COMPLAINT THAT DURING WITHDRAWAL OF THE NEEDLE, THE CANNULA DETACHED AND REMAINED UNDER THE SKIN OF THE PATIENT. AN ATTEMPT TO REMOVE THE DETACHED PORTION OF CANNULA FROM THE PATIENT WAS UNSUCCESSFUL. NO PERMANENT ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12626 CLEO 90 INFUSION SET FPA - SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7221 72X004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention