BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27G CANNULA SET WITH HIGH FLOW INFUSION LINE

    MDR report key: 16416047 · Received February 22, 2023

    Report

    Report Number
    1222074-2023-00014
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 26, 2023
    Report Date
    April 19, 2023
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    NGY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN REGARD TO THIS COMPLAINT, AN AVETA INFUSION LINE AND TWO CANNULA'S WITH CLOSURE VALVES WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION SHOWED NO ANOMALIES. THE CLOSURE VALVES WERE INTACT. THOUGH THE VIDEO'S THAT WERE RECEIVED FROM THE CUSTOMER CLEARLY DEMONSTRATED AIR LEAKAGE AT THE CONNECTION BETWEEN THE INFUSION LINE AND THE CANNULA'S, IT SHOULD BE NOTED THAT SOME LEAKAGE IS IN FACT ALLOWED. TESTING IN ACCORDANCE WITH THE APPLICABLE TEST PROTOCOL REVEALED THAT THE MAXIMUM WATER LEAKAGE OF 0.4 ML/MIN AT 40 MMHG WAS NOT EXCEEDED. BASED ON THE INVESTIGATION PERFORMED, IT WAS CONCLUDED THAT THE VALVES MET THEIR SPECIFICATION. IN 2022 AN INCREASE IN COMPLAINT RATE WAS OBSERVED, WHICH TRIGGERED A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS. AS A RESULT THE DRYING TIME WAS INCREASED, AS THIS WAS CONSIDERED THE CAUSE OF THE INCREASE IN COMPLAINTS OBSERVED. PER ECF 2022-390, A CHANGE WAS INITIATED TO INCREASE THE DRYING TIME BETWEEN GLUE APPLICATION AND NEXT STEPS OF ASSEMBLY. THE CHANGE WAS IMPLEMENTED WITH AN UPDATE OF ALL RELEVANT WORK INSTRUCTIONS. THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODES CI-INF-LEAKAGE, CI-CLOSURE VALVE-LEAKAGE AND CI-CLOSURE VALVE-DEFECT-REMOVAL RELATED TO COMPARABLE TROCAR SYSTEMS.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE, A LEAK WAS NOTICED FROM THE CONNECTION BETWEEN THE TROCAR AND THE INFUSION TUBE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE, A LEAK WAS NOTICED FROM THE CONNECTION BETWEEN THE TROCAR AND THE INFUSION TUBE. NO REPORT THAT ACTUAL HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676817 27G CANNULA SET WITH HIGH FLOW INFUSION LINE OPHTHALMIC CANNULATION SET, SINGLE-USE NGY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2000436829

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown