BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEO INFUSION SET

    MDR report key: 11477978 · Received March 12, 2021

    Report

    Report Number
    3012307300-2021-02039
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    October 6, 2020
    Report Date
    June 15, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586028397
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION RECEIVED VIA (EMAIL) ON 13 MAY 2021 WE PROVIDED THE INCORRECT LOT NUMBER FOR COMPLAINT (B)(4). ORIGINALLY IT WAS THOUGHT THAT THE IMPACT LOT WAS 3900361, HOWEVER DURING OUR INVESTIGATION IT WAS DETERMINED THAT THE IMPACT LOT WAS 3900357.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED A PATIENT HAD PANNICULITIS AND DEEP ABSCESS INFECTION WITH STAPH AUREUS WHILE USING A SMITHS MEDICAL CADD CLEO INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366840 CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 3900357 10610586028397

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention