BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE

    MDR report key: 10945732 · Received December 3, 2020

    Report

    Report Number
    MW5098201
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 2, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE HAD 6 LEAKING CADDS. THE IV ROOM TECHNICIAN NOTICED THE LEAKING DURING PREPARATION. LEAKING CADDS DID NOT REACH A PATIENT. 100 ML CADD REF: 21-7302-24, MANUFACTURER SMITHS MEDICAL ASD, INC. LOT NUMBER 4013377, EXP: 2025-07- 23 AND 4037753, EXP: 2025-08-18. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408036 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4013377
    1408037 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4037753
    1408038 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1408039 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1408040 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1408041 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1