BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 9196654 · Received October 16, 2019

    Report

    Report Number
    9196654
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 1, 2019
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT HOME ON AN AMBULATORY INFUSION PUMP. PATIENT RETURNED TO THE LCI AFTER SHE DISCOVERED THAT THE TUBING BROKE OFF OF THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992102 CADD PUMP, INFUSION FRN SMITHS MEDICAL MD, INC. 3674591

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA