BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 3760954 · Received April 10, 2014

    Report

    Report Number
    2183502-2014-00196
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 9, 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

    MANUFACTURER COMPLETED THE ENTIRE FORM. 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

    A REPORT WAS RECEIVED ALLEGING THAT WHEN REMOVING THE DEVICE FOR USE, A PORTION OF THE CANNULA BROKE OFF AND REMAINED UNDER THE USER'S SKIN. THE REPORT STATES THAT THE SITE BECAME INFLAMED AND THE PATIENT WAS BROUGHT TO THE ER ON (B)(6) 2014. WHILE AT THE ER, PATIENT WAS PRESCRIBED A COURSE OF ANTIBIOTICS AND INSTRUCTED TO RETURN THE FOLLOWING DAY, (B)(6) 2014, FOR X-RAY AND ULTRASOUND. AFTER SURGEON REVIEWED THE X-RAY AND ULTRASOUND, NO FURTHER ACTION WAS RECOMMENDED TO REMOVE THE CANNULA. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216440 CLEO 90 INFUSION SET FPA - SUBCUTANEOUS INFUSION SET FPA SMITHS MEDICAL 21-7220 72X075

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization