BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13094393 · Received December 28, 2021

    Report

    Report Number
    3012307300-2021-13343
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    November 18, 2021
    Report Date
    March 18, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION . H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. SAMPLE RECEIVED: ONE (1) SAMPLE WERE RECEIVED FROM P/N 21-7106-24 L/N 4101719 IN NEW CONDITIONS, WITH ITS ORIGINAL OPEN PACKAGING. LEAK TEST: THE SAMPLE WAS TESTED USING A SYRINGE WITH COLORED WATER. RESULTS: DURING THE TEST, SAMPLE A LEAK WERE FOUND BETWEEN THE FILTER AND TUBE. THE COMPLAINT IS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS, ROOT CAUSE IS LACK OF SOLVENT BY NOT FOLLOWING THE MANUFACTURING PROCEDURE. AWARENESS NOTIFICATION WAS MADE TO PRODUCTION PERSONNEL IN ORDER TO EXPLAIN THE IMPORTANCE TO ADHERENCE OR FOLLOWING IN THE PROCEDURE MP-366 REV.112 ?EXTENSION SET WITH FILTER ASSEMBLY? SECTION 12.0 BOND COILED TUBE ASSEMBLY TO FILTER INLET, BY QUALITY ENGINEER ON (B)(6) 2022.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED REGARDING A CADD EXTENSION SET. IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, A CRACK WAS FOUND IN THE CONNECTION BETWEEN THE FILTER AND THE TUBE, WHERE LEAKAGE OF MEDICAL FLUID WAS DETECTED. THERE WAS NO PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997095 CADD INTRAVASCULAR ADMINISTRATION SET FPA ST PAUL 21-7106-24 4101719 10610586023279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown