BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS3 CARTRIDGES

    MDR report key: 15640765 · Received October 20, 2022

    Report

    Report Number
    3012307300-2022-25485
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Report Date
    August 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION RECEIVED VIA (EMAIL) ON 03 NOV 2022 BATCH 7022942 HAS BEEN REPORTED. THE CAP WAS REPLACED. THE PROBLEM WITH THE PRODUCT DID NOT CAUSE INJURY TO THE PATIENT. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. H10: DEVICE EVALUATION 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.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. MOST PROBABLE CAUSE IS USER ISSUE; HOWEVER, THIS CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. NO SERIAL NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED. NO INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO CHARGE OF THE CARTRIDGE. THERE WAS NO PATIENT ASSOCIATED WITH THIS OCCURRENCE. THE EVENT OCCURRED PRIOR TO USE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148168 CADD MS3 CARTRIDGES PUMP, INFUSION FRN ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown