BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11325292 · Received February 12, 2021

    Report

    Report Number
    3012307300-2021-01196
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    November 21, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EIGHT SAMPLES WERE RETURNED. FOUR OF WHICH WERE DECONTAMINATED WITHOUT ORIGINAL PACKAGING AND FOUR WERE NEW AND IN ORIGINAL PACKAGING. THE SAMPLES RETURNED WERE 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 THREE (3) DECONTAMINATED SAMPLES, THUS THE FAILURE MODE REPORTED IS CONFIRMED, THE FIVE (5) REMAINING SAMPLES NO LEAK FOUND. 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 REGARDING A CADD EXTENSION SETS . IT WAS REPORTED THAT THE EXTENSION SETS WERE LEAKING AT THE HEIGHT OF THE FILTER. THIS OCCURRED WHILE IN USE WITH A PATIENT. NO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217615 CADD INTRAVASCULAR ADMINISTRATION SET FPA ST PAUL 21-7106-24 3983999 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1