BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD COMPUTERIZED AMBULATORY DELIVERY DEVICE

    MDR report key: 19659911 · Received July 1, 2024

    Report

    Report Number
    MW5156934
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 27, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HAIR FOUND IN STERILE CADD(COMPUTERIZED AMBULATORY DELIVERY DEVICE) 100ML CONTAINER BETWEEN THE CASSETTE AND INNER BAG. PRODUCT MANUFACTURED BY SMITHS MEDICAL ASD, INC. POTENTIAL LOTS AFFECTED # 4453445 OR #4461345.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552141 CADD COMPUTERIZED AMBULATORY DELIVERY DEVICE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4461345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown