BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11266212 · Received February 2, 2021

    Report

    Report Number
    3012307300-2021-00762
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    December 22, 2020
    Report Date
    April 28, 2021
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: THREE PICTURES AND ONE SAMPLE WERE RETURNED FOR ANALYSIS. THE SAMPLE RETURNED WAS TESTED USING THE HYDROSTATIC VESSEL [CAL ID: 8.0088 DUE DATE: JANUARY 2022] AS PROCEDURE PQ-016 HYDROSTATIC PRESSURE TEST (LEAK TEST) REV. 103 INDICATE. 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 WHILE IN USE OF A SMITHS MEDICAL CADD EXTENSION SET, THE CUSTOMER NOTICED THAT THERE WAS MEDICAL FLUID LEAKING FROM THE FILTER. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161347 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1