BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO INFUSION SET

    MDR report key: 10303884 · Received July 21, 2020

    Report

    Report Number
    3012307300-2020-07477
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    February 11, 2020
    Report Date
    July 21, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    30610586028339
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD A SKIN INFECTION AT THE INFUSION SITE AFTER THE USE OF A SMITHS MEDICAL CADD CLEO INFUSION SET. PRIMICILLIN 800 MG X 4 / DAY FOR ONE WEEK WAS PRESCRIBED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765872 CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7220-24 3676600 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention