BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT

    MDR report key: 22206531 · Received June 13, 2025

    Report

    Report Number
    9617604-2025-00229
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 31, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    LHI
    UDI-DI
    10610586044014
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE NUMBER 3012307300-2025-09136-00 FOR DETAILS PERTINENT TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AN EMAIL WAS RECEIVED REGARDING A MEDICATION CASSETTE WITH ITEM NUMBER 21-7609-24 AND LOT NUMBER 6012373. IT WAS STATED LIQUID LEAKAGE FROM THE CONNECTOR PART. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353284 CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6012373 10610586044014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown