BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION SET CLEO 24 INCHES 9MM

    MDR report key: 21277992 · Received January 30, 2025

    Report

    Report Number
    3012307300-2025-01372
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 11, 2024
    Report Date
    March 12, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3: CORRECTION. H3: NEITHER SAMPLE OR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. NO DEVICE HISTORY RECORD WAS REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. WITHOUT THE RETURN OF THE USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/B5.JSF#.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS JUST STARTED USING THE CLEO TUBING WHEN IT BEGAN LEAKING, CAUSING THE NEED TO SWITCH TO A DIFFERENT SUBCUTANEOUS SITE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519580 INFUSION SET CLEO 24 INCHES 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male LIDOCAINE/PRILOCAINE CREAM| TRIAMCINOLONE ACETONIDE CREAM| WINREVAIR SDV