BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 19801321 · Received July 22, 2024

    Report

    Report Number
    3012307300-2024-06458
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    March 2, 2024
    Report Date
    August 23, 2024
    Manufacturer
    SMITHS MEDICAL MD, INC
    Product Code
    FPA
    UDI-DI
    10610586027505
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 3910205 WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE USED SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PCA TUBING WAS FOUND TO BE LEAKING AT CONNECTION SITE WITH IV FLUIDS. THE ORIGINAL INTENDED PROCEDURE WAS IV INFUSION. THE DEVICE HAD FAILED. IT BROKE AND THE CUSTOMER COULD NOT GET IT TO WORK, OR THE DEVICE HAD STOPPED WORKING. THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THE DEVICE WAS HARD TO USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440972 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD, INC 3910205 10610586027505

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male