BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SET

    MDR report key: 9512698 · Received December 23, 2019

    Report

    Report Number
    3012307300-2019-07050
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Report Date
    July 28, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586029653
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, H6, H10 DEVICE EVALUATION: ONE CADD ADMINISTRATION SETS WAS RETURNED FOR ANALYSIS. THE SAMPLE CONSIST OF ONE PRODUCT FROM P/N 21-7324-24 L/N 3840903; THE SAMPLE RETURNED WAS RECEIVED IN USED CONDITIONS INSIDE A PLASTIC BAG WITH IT ORIGINAL PACKAGING. THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION MD01-003 AND DELAMINATION WAS FOUND IN THE JOIN BETWEEN THE PUMP TUBE AND THE TUBE 105". FUNCTIONAL LEAK TESTING ON THE SAMPLES RECEIVED WERE PERFORMED USING HYDROSTAT VESSEL TO LOOK FOR UNUSUAL FUNCTIONS AND LEAK WAS OBSERVED FLEEING FROM THE BONDING BETWEEN THE TUBING 105" AND PUMP TUBE. THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE LEAKING FROM TUBES, FURTHER INVESTIGATION WAS PERFORMED AND REPORTED THAT THE MOST PROBABLE ROOT CAUSE IS A LACK/INSUFFICIENT CYCLOHEXANONE ADHESIVE IS GENERATE FOR THE VARIABLES THAT HAVE THE PROCESS FOR THE SOLVENT APPLICATION TO THE TUBE. THE PROBLEM SOURCE OF THE REPORTED PROBLEM IS MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD ADMINISTRATION SET, THE SET WAS INSERTED INTO A CADD PUMP AND AFTER APPROXIMATELY 15 MINUTES, THE USER NOTICED A LEAKAGE BETWEEN THE JUNCTION TUBING- PUMP. THE REPORTER INDICATED THAT THE CUSTOMER ASSUMED IT WAS A CADD SET ISSUE SO THE CADD SET WAS CHANGED WITH ANOTHER ONE AND THE BOLUS ADMINISTRATION WAS SUCCESSFUL. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305721 CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7324-01 3840903 10610586029653

    Patients

    Seq Age Sex Outcome Treatment
    1