BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 9978207 · Received April 20, 2020

    Report

    Report Number
    3012307300-2020-03344
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 19, 2020
    Report Date
    December 24, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP THE SAMPLE CONSIST OF ONE (1) PRODUCT FROM P/N 21-7302-24 L/N 3882472 THE RETURNED SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGED. UPON VISUAL INSPECTION NO DISCREPANCIES. DURING FUNCTIONAL TESTING PERFORMED USING SYRINGE AND LEAK WAS DETECTED. ENGINEERING TESTING REVIEWED AND PERFORMED 100% WITH NO DISCREPANCIES. ROOT CAUSE INVESTIGATION AND CORRECTIVE ACTIONS WILL BE FOLLOW BY CAPA PROCESS, THROUGH CAPA(B)(4) OPEN ON SEPTEMBER 22ND 2020. BY THE DATE THAT THIS INVESTIGATION REPORT IS DOCUMENTED CAPA (B)(6) IS UNDER SOLUTION PLAN PHASE. THE EXPECTED DUE DATE OF THIS INVESTIGATION PHASE IS JANUARY 8TH 2021.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED.

    Description of Event or Problem · 1

    AFTER FILLING DEVICE OPERATOR NOTICED PRODUCT WAS LEAKING INTO CASSETTE, NO PHOTO AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 26 MAR, 2020. THE REPORTED EVENT OCCURRED ON (B)(6) 2020 WHILE NOT IN USE WITH A PATIENT BUT DURING THE FILLING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442808 CADD FPA ST PAUL 21-7302-24 3882472 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1