BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 24" 6MM

    MDR report key: 24033218 · Received January 12, 2026

    Report

    Report Number
    MW5182006
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Report Date
    January 5, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT'S FATHER REPORTS THAT WITH THE PT'S PAST 2 SITES, THE CLEO CATHETER TIP WAS FOUND BROKEN OFF & THEY ARE UNSURE WHERE IT HAS BEEN LODGING IN THE PT. FATHER BELIEVES IT IS A DEFECT WITH CLEO LOT NUMBER 6092951 (EXPIRATION DATE UNKNOWN). FATHER REPORTS THE PT HAD AN APPOINTMENT WITH THE MD AFTER THE FIRST TIME THIS HAPPENED & FOLLOWED UP. FATHER ADVISED THE MD SUGGESTED THEY WAIT & SEE IF THE AREA GETS RED, ITCHY OR INFECTED OR THE PT MAY NEED TO GET AN ULTRASOUND. FATHER REFUSED THE ULTRASOUND, CHOOSING INSTEAD TO WAIT & STATES THE AREA SEEMS HEALED. FATHER REPORTS THE AREA UNDER WHERE THE PT'S CATHETER IS PLACED IS SOMEWHAT HARD BUT SEEMS NORMAL. RPH (REGISTERED PHARMACIST) ADVISED FATHER TO FOLLOW UP WITH THE MD OFFICE REGARDING AN ULTRASOUND FOR PT, CNSS (CLINICAL NURSE SPECIALIST) ASSIGNED TO DISCUSS DETAILS & RPH ADVISED FATHER TO CALL 911 IF THIS WERE TO HAPPEN AGAIN. NO FURTHER INFO, DETAILS, OR DATES AVAILABLE. PT'S CURRENT REMODULIN DOSE: 100NG/KG/MIN. SQ(SUBCUTANOEUS)REMUNITY SELF-FILL PT VIA REMUNITY PUMP. PT STARTED USING REMUNITY DEVICE (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107327 INF SET CLEO 24" 6MM SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 6092951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female AMBRISENTAN.| TADLIQ.