BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INF SET CLEO 42" 9MM

    MDR report key: 10747697 · Received October 27, 2020

    Report

    Report Number
    MW5097484
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    October 2, 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

    SOLICITED PT REPORTS ONE INSTANCE OF TUBING NOT WORKING BECAUSE MEDICATION WAS NOT GOING THROUGH IT. NO OTHER INFO IS AVAILABLE. PLEASE NOTE: UNABLE TO FIND LOT NUMBER. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209389 INF SET CLEO 42" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21723224

    Patients

    Seq Age Sex Outcome Treatment
    1