BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SETS

    MDR report key: 15655091 · Received October 21, 2022

    Report

    Report Number
    3012307300-2022-25834
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    October 7, 2022
    Report Date
    June 13, 2023
    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

    H10: DEVICE EVALUATION: TWO PICTURES WERE RECEIVED AND REVIEWED. PICTURE ONE SHOWS AN EXTENSION OUTSIDE OF ITS ORIGINAL PACKAGING. PICTURE TWO SHOWS A UNION BETWEEN FEMALE LUER AND CONNECTOR WITH A LEAK. ONE SAMPLE WAS RETURNED FOR EVALUATION OF THE FAILURE MODE; THE UNIT RETURNED WAS RECEIVED INSIDE OF A PLASTIC BAG WITH THEIR ORIGINAL PACKAGING OPEN AND DECONTAMINATED. THE SAMPLE WAS TESTED USING A SYRINGE. COLORED WATER WAS PASSED THROUGH THE EXTENSION SET TO DETECT ANY LEAK; DURING TESTING, A LEAKAGE WAS FOUND IN THE SAMPLE UNION BETWEEN THE CONNECTOR AND THE EXTENSION TUBE. THE COMPLAINT WAS CONFIRMED. BASED ON THE ANALYSIS CONDUCTED IN THE SAMPLE PROVIDED THE ISSUE WAS DUE TO A LACK OF SOLVENT. THE FAILURE CONDITION WAS POSSIBLY DUE TO THE ASSEMBLY PROCESS NOT BEING FOLLOWED CORRECTLY. FAILURE WAS TRACED TO MANUFACTURING. FOR CORRECTIVE ACTION AN AWARENESS/CUSTOMER COMPLAINT NOTIFICATION WAS PERFORMED TO PRODUCTION PERSONNEL TO EXPLAIN THE IMPORTANCE OF ADHERENCE TO MANUFACTURING PROCEDURE A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF MEDICAL FLUID FROM THE CONNECTOR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647479 CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7605-24 4279903 10610586044113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown