BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN VIOLET8/0(0.4)45CM2XDLM6S200M

    MDR report key: 8813421 · Received July 22, 2019

    Report

    Report Number
    3003639970-2019-00546
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    June 19, 2019
    Report Date
    October 7, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION - ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO MAKE A DECISION. NOVOSYN BIOCOMPATIBILITY HAS BEEN TESTED IN SEVERAL EXPERIMENTS. IN SENSITIZATION AND IRRITATION TESTS THE HARMLESSNESS OF NOVOSYN WAS PROVEN. WE HAVE CHECKED THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND THERE WERE TWO INTERNAL NON-CONFORMITIES. AFTER THE REPROCESSING OF THE PRODUCT, THE RESULTS BEFORE RELEASING THE PRODUCT FULFILLED B.BRAUN SURGICAL REQUIREMENTS. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.124 KGF IN AVERAGE AND 0.106 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 0.071 KGF IN AVERAGE AND 0.036 KGF IN MINIMUM). ADDITIONALLY, WE HAVE CHECKED THE COMPLAINT HISTORY RECORD, AND THERE ARE NO PREVIOUS COMPLAINTS FOR THIS REFERENCE (G0068713) IN THE LAST FIVE YEARS NOR PREVIOUS COMPLAINT FOR THIS ISSUE TO THE OTHER PRODUCTS MANUFACTURED WITH THE SAME RAW MATERIAL BATCH AS THE USED IN THE PRODUCTION OF THE INVOLVED BATCH. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED.

    Additional Manufacturer Narrative · 1

    PMA/510K #: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K122734. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE PROBLEMS WITH THE SUTURES. THE THREAD BROKE AND PATIENT HAD A REACTION. ON (B)(6) 2019 A PATIENT HAD SURGERY OF TRABECULECTOMY USING THE SUTURE THREAD NOVOSIN 8/0. ON (B)(6) 2019 IT WAS REPORTED THAT TWO THREADS BROKE IN THE INITIAL PHASE OF VITRECTOMY, AT THE MOMENT OF THE PLACEMENT OF THE SECURITY SUTURE. NO COMPLICATIONS AND NO CONSEQUENCES SINCE PROBLEM OCCURRED AT THE START OF THE SURGERY, BUT IF IT OCCURRED AT THE END OF THE SURGERY, SERIOUS HARM FOR THE PATIENT WOULD BE OCCURRED. ON (B)(6) 2019 THE PATIENT HAD SURGERY AGAIN FOR A COMPLICATION (SEIDEL AND HYPOTONIA) DUE TO THE SPONTANEOUS REACTION WITH THE USED SUTURE. CONJUNCTIVAL SUTURE WAS PERFORMED FOLLOWING THE GUIDE LINES AND KNOTTING THE THREAD FOR 3 TIMES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607779 NOVOSYN VIOLET8/0(0.4)45CM2XDLM6S200M SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA G0068713 118432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention