BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11177951 · Received January 15, 2021

    Report

    Report Number
    3012307300-2021-00473
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 16, 2020
    Report Date
    April 27, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586023279
    PMA / PMN Number
    K974013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: THREE PICTURES AND ONE UNIT WAS RETURNED FOR ANALYSIS. A LEAK WAS FOUND FLEEING FROM THE AIR VENT OF THE FILTER IN DECONTAMINATED SAMPLE, THUS THE FAILURE MODE REPORTED IS CONFIRMED. ROOT CAUSE ANALYSIS OF THIS FAILURE MODE WAS PERFORMED UNDER CAPA-000542 OPEN ON 30-APR-2019, ON WHICH ROOT CAUSE STATES FILTER LEAKAGE IS CAUSED SILICON OIL TRANSFERRED FROM THE SYRINGES AND/OR VIALS INTO MEDICATION RESERVOIR DURING THE FILLING PROCESS BY THE CUSTOMER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THE CADD EXTENSION SET, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74872 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7106-24 4016660 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1