BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 10559820 · Received September 18, 2020

    Report

    Report Number
    MW5096759
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Report Date
    August 26, 2020
    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 CONTACT: PATIENT STATED TUBING WERE NOT WORKING WELL FOR THE PATIENT AND HE HAD TO CHANGE IT A FEW TIMES. NO OTHER INFORMATION KNOWN. NO SIDE EFFECTS OR SYMPTOMS REPORTED. DEFECTIVE PRODUCT IS NOT AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021715 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723124

    Patients

    Seq Age Sex Outcome Treatment
    1