BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 42" 9MM

    MDR report key: 11337583 · Received February 16, 2021

    Report

    Report Number
    MW5099423
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 23, 2021
    Report Date
    January 23, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT HAVING TROUBLE GETTING HER CLEO TUBING TO PROPERLY FILL WHEN DOING CARTRIDGE CHANGE. SHE HAD TWO MALFUNCTIONS WITH THE CLEO TUBING. THE LOT NUMBERS ARE# 3965601 AND # 4031119. THE THIRD ONE WORKED. NO SIDE EFFECTS FOR PATIENT. NO OTHER INFO KNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232891 INF SET CLEO 42" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723224 3965601
    232892 INF SET CLEO 42" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723224 4031119

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR