BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 21904036 · Received April 24, 2025

    Report

    Report Number
    9617604-2025-00211
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    March 1, 2025
    Report Date
    April 24, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027536
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DAY OF EVENT UNKNOWN. D4: POSSIBLE LOTS 6026761 AND 6012546. H3: THE DEVICE HISTORY RECORD OF REPORTED POSSIBLE LOTS 6026761 AND 6012546 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. COMPLAINT FOR THE FAILURE MODE COULD NOT BE CONFIRMED BY INVESTIGATION AS NO SAMPLES NOR PICTURES WERE PROVIDED BY THE CUSTOMER. 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 SCREEN READS RESERVOIR EMPTY, ACCOMPANIED BY A BEEPING SOUND AS EXPECTED. HOWEVER, 40 ML HAD REMAINED IN THE BAG, APPROXIMATELY 30% OF THE ORDERED DOSE. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT BUT NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227936 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 10610586027536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown