BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27G CANNULA SET WITH HIGH FLOW INFUSION LINE

    MDR report key: 16511156 · Received March 9, 2023

    Report

    Report Number
    1222074-2023-00020
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 15, 2023
    Report Date
    May 3, 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, ONE COMPLETE TROCAR, ONE INSERTER AND ONE INFUSION LINE-CANNULA COMBINATION WERE RECEIVED FOR INVESTIGATION. THE INFUSION LINE SHOWED SOME MINOR TRACES OF USE AND THE STAR INCISION IN THE CLOSURE VALVE OF THE INFUSION LINE-CANNULA COMBINATION APPEARS TO BE OFF-CENTERED. WHILE ACTUAL DAMAGE WAS NOT OBSERVED, THE CLOSURE VALVE DOES NOT SEEM TO CLOSE PROPERLY. TESTING CONFIRMED LEAKAGE FROM THE CLOSURE VALVE AND DEMONSTRATED THAT IT EXCEEDED THE MAXIMUM ALLOWED LEAKAGE OF 0.4 ML/MIN AT 40 MMHG. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS. THOUGH THERE SEEMED TO BE NO DAMAGE TO THE VALVE, IT IS VERY WELL POSSIBLE THAT THE VALVE WAS INITIALLY STUCK TO THE INSERTER. DUE TO SUCH AN ADHESION, THE VALVE MAY NOT CLOSE COMPLETELY AND LEAKAGE IS FACILITATED. DUE TO A RECENT INCREASE OF SIMILAR COMPLAINTS, A BROADER INVESTIGATION AS TO THE CAUSE OF THIS FAILURE HAS BEEN INITIATED. A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS REVEALED THAT WHEN THE DRYING TIME OF THE APPLIED GLUE ON THE CAP OF THE PRODUCT IS TOO SHORT FOR THE VOLUME OF GLUE DISPENSED, VALVES MAY IN SOME CASES BECOME STICKY. THEREFORE, THE MOST PLAUSIBLE ROOT CAUSE OF THIS COMPLAINT IS CONSIDERED A STICKY VALVE DUE TO INSUFFICIENT DRYING TIME OF GLUE IN RELATION TO THE VOLUME OF GLUE APPLIED. IN 2022 AN INCREASE IN COMPLAINT RATE WAS OBSERVED, WHICH TRIGGERED A DETAILED INVESTIGATION OF THE MANUFACTURING PROCESS. AS A RESULT THE DRY TIME WILL BE 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. AS OF 07OCT22 ALL AVETA TROCARS ARE ASSEMBLED IN ACCORDANCE WITH THE UPDATED WORK INSTRUCTIONS.THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODES CI-CLOSUREVALVE-LEAKAGE, CI-INF-LEAKAGE AND CI-CLOSUREVALVE-DEFECT-REMOVAL RELATED TO COMPARABLE TROCAR SYSTEMS (DISTRIBUTION FIGURES UP TO AND INCLUDING MARCH 2023).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE, IT WAS NOTED THAT FLUID LEAKED FROM THE CANNULA AND PERFUSATE LEAKED FROM THE CONNECTION BETWEEN THE CANNULA 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, IT WAS NOTED THAT FLUID LEAKED FROM THE CANNULA AND PERFUSATE LEAKED FROM THE CONNECTION BETWEEN THE CANNULA 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
    531311 27G CANNULA SET WITH HIGH FLOW INFUSION LINE OPHTHALMIC CANNULATION SET, SINGLE-USE NGY D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. OPHTHALMIC CANNULATION SET, SI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown