BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12158013 · Received July 13, 2021

    Report

    Report Number
    3012307300-2021-07157
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 1, 2021
    Report Date
    March 3, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586044113
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS RECEIVED FROM P/N 21-7605-24 L/N 3965608 IN USED CONDITIONS, WITH ITS ORIGINAL OPEN PACKAGING. LEAK TEST: SAMPLE WAS TESTED USING A SYRINGE WITH COLORED WATER. RESULTS: DURING THE TEST, LEAK WAS FOUND BETWEEN LUER 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 FOLLOWED TO PROCEDURE PM-417 REV.109 ?ASSEMBLY, EXTENSION SET? SECTION 4.0 ?BOND MALE LUER TO LONG TUBE WITH CLAMP?. AWARENESS NOTIFICATION WAS MADE TO PRODUCTION PERSONNEL IN ORDER TO EXPLAIN THE IMPORTANCE TO ADHERENCE OR FOLLOWING IN THE PROCEDURE PM-417 REV.109 ?ASSEMBLY, EXTENSION SET? SECTION 4.0? BOND MALE LUER TO LONG TUBE WITH CLAMP?, BY QUALITY ENGINEER ON 07/SEP/2021.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING DURING USE OF THE SMITHS MEDICAL CADD EXTENSION SET, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE CONNECTION PART. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056338 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7605-24 3965608 10610586044113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown