BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE, 100ML RESERVOIR

    MDR report key: 21152734 · Received January 14, 2025

    Report

    Report Number
    3012307300-2025-00712
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 14, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT NUMBERS 6004936, 6012477, 6005594, 6022037, AND 6012478 H3: NEITHER SAMPLES NOR PICTURES WERE RECEIVED FOR THE ANALYSIS OF THIS COMPLAINT. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER: 6004936, 6012477, 6005594, 6022037, AND 6012478 WERE 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 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 THE DEVICE HAD PARTICLES FOUND INSIDE THE BAG. ONLY ONE CASSETTE WAS FOUND WITH THE PARTICLES, BUT THE CUSTOMER HAD NO WAY OF KNOWING WHICH LOT WAS INVOLVED. THE EVENT OCCURRED DURING VISUAL INSPECTION AFTER THE CASSETTE WAS FILLED WITH PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211876 CADD CASSETTE, 100ML RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. UNKNOWN 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown