BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN SUTURE

    MDR report key: 7861535 · Received September 10, 2018

    Report

    Report Number
    3003639970-2018-00552
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    April 13, 2018
    Report Date
    October 25, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: INCIDENT REPORTED RELATED TO SUTURE TYPE, SPECIFIC ITEM NUMBER/BATCH NUMBER IS UNKNOWN. PENDING FURTHER INFORMATION. NOTE: SUBMISSION OF THIS MEDWATCH WAS ATTEMPTED TO BE COMPLETED ON SATURDAY SEPTEMBER 8, 2018; HOWEVER, THE GATEWAY FOR WEBTRADER USERS WAS UNAVAILABLE AND THE SUBMISSION COULD NOT BE COMPLETED AT THAT TIME.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: DEVICE NOT IMPLANTED OR EXPLANTED. ALL MEDWATCH SUBMISSIONS RELATED TO THIS PATIENT ARE: 3003639970-2018-00551. ADDITIONAL INFORMATION RECEIVED ON 26SEP2018: THE HOSPITAL HAS DONE BACTERIA CULTURE ON SOME CASES BUT NOT ALL OT THEM. THEY HAVE INFORMED THAT SUTURE HAS CAUSED LIKE AN INFECTION SYMPTOM AND IT HAS CALMED DOWN WHEN THE SUTURE HAS BEEN REMOVED. IN THOSE CASES WHERE THEY HAVE SEEN THAT SUTURE HAS CAUSED THE PROBLEM THEY HAVE NOT TOOK BACTERIA CULTURE. THEY HAVE FOLLOWED THE SITUATION ON THE WOUND AND HOW IT HAS DEVELOPED. SEE THE LIST OF CASES WHERE THEY HAVE DONE BACTERIAL CULTURES: 6 CASES RESULT NEGATIVE, 4 CASES NORMAL "MIXED" SKIN FLORA, 1 CASE STAPH. AUREUS, 2 CASES STREPT. DYSGALACTIAE EQUISIMILIS AND 1 CASE FINEGOLDIA MAGNA. INVESTIGATION RECEIVED ON 01OCT2018: SAMPLES RECEIVED: 9 UNOPENED POUCHES.(MODEL C0069014, LOT 115233, EXPIRATION DATE 03JUN2018). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 936 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. STERILIZATION METHOD USING ETHYLENE OXIDE HAS BEEN VALIDATED FOR THIS PRODUCT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. STERILIZATION PROCESS WAS ALSO NORMAL AND THE RESULTS OF THE STERILIZATION CONTROL ARE CORRECT. WE HAVE RECEIVED NINE CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE CLOSED SAMPLES FOR: KNOT PULL TENSILE STRENGTH AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 2.32 KGF IN AVERAGE AND 2.15 KGF IN MINIMUM (EP REQUIREMENTS: 1.81 KGF IN AVERAGE AND 0.91 KGF IN MINIMUM). KNOT SECURITY CONTROL AND RESULTS ARE INTO THE CURRENT RANGE FOR THIS THREAD AND SIZE. DEGRADATION TEST AND THE RESULTS FULFIL B. BRAUN SURGICAL (BBS) REQUIREMENTS. IN THE DEGRADATION TEST, THREADS ARE INTRODUCED IN A 0.9 % NACL SOLUTION AT 37ºC FOR 14 DAYS. AFTER THIS PERIOD, THE KNOT PULL TENSILE STRENGTH OF THE THREAD IS TESTED. THE RESULTS FOR THE CLOSED SAMPLES RECEIVED ARE 1.81 KGF IN AVERAGE AND 1.74 KGF IN MINIMUM (B. BRAUN SURGICAL REQUIREMENT IS 0.94 KGF IN MINIMUM). ACCORDING TO THE RESULTS OF THE TESTS REALIZED TO THE CLOSED SAMPLES RECEIVED FROM THE CUSTOMER AND THE BATCH MANUFACTURING RECORDS REVIEW, THE PRODUCTS COMPLY WITH OUR SPECIFICATIONS; THEREFORE WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. AS STATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: " MODE OF ACTION: SUTURE MATERIALS ARE USED PRIMARILY FOR ADAPTATION OF THE WOUND EDGES TO RENDER POSSIBLE AND UNDISTURBED WOUND HEALING. UPON IMPLANTATION OF NOVOSYN SUTURES A MILD INFLAMMATORY REACTION MAY OCCUR, WHICH IS TYPICAL OF AN ENDOGENOUS REACTION TO FOREIGN BODIES. AS TIME PASSES, THE SUTURE MATERIAL IS ENCAPSULATED BY FIBROUS CONNECTIVE TISSUE. NOVOSYN IS METABOLIZED TO GLYCOLIC ACID AND LACTIC ACID BY HYDROLYSIS WITHOUT CAUSING ANY ENDURING ALTERATIONS OF THE IMPLANTATION SITE. ABOUT 75% OF THE ORIGINAL TENSILE STRENGTH REMAINS AFTER 14 DAYS OF IMPLANTATION, ABOUT 40-50% AFTER 21 DAYS AND ABOUT 25% AFTER 28 DAYS. THE COMPLETE MASS ABSORPTION OF NOVOSYN TAKES PLACE AT 56-70 DAYS, WHEN THE TISSUE IS NORMALLY PERFUSED. CONTRA-INDICATIONS: NOVOSYN® SUTURE MATERIALS ARE CONTRA-INDICATED FOR APPLICATIONS WHERE PROLONGED SUPPORT OF THE WOUND CLOSURE BY THE SUTURE MATERIAL IS REQUIRED (E.G. CARDIO-VASCULAR SURGERY). NOTES / WARNINGS / PRECAUTIONARY MEASURES: USERS SHOULD BE FAMILIAR WITH THE SURGICAL PROCEDURES AND TECHNIQUES INVOLVING ABSORBABLE SUTURES WHEN USING NOVOSYN®, AS THE RISK OF WOUND DEHISCENCE MAY VARY DEPENDING UPON THE SITE OF APPLICATION AND THE TYPE OF MATERIAL USED. SKIN SUTURES WHICH REMAIN IN PLACE LONGER THAN 7 DAYS MAY CAUSE LOCALIZED IRRITATION AND SHOULD BE SNIPPED OFF OR REMOVED AS INDICATED. CONSIDERATION SHOULD BE TAKEN IN THE USE OF ABSORBABLE SUTURES IN TISSUES WITH POOR BLOOD SUPPLY AS SUTURE EXTRUSION AND DELAYED ABSORPTION MAY OCCUR. SUBCUTICULAR SUTURES SHOULD BE PLACED AS DEEPLY AS POSSIBLE TO MINIMIZE THE ERYTHEMA AND INDURATION NORMALLY ASSOCIATED WITH THE ABSORPTION PROCESS. USAGE OF NOVOSYN® MAY NOT BE ADVISED IN CASE OF ELDERLY OR MALNOURISHED OR DEBILITATED PATIENTS, OR IN PATIENTS SUFFERING FROM DISEASES OR CONDITIONS WHICH DELAY THE WOUND HEALING PROCESS. SIDE EFFECTS: AN EXISTING INFECTION MAY BE NEGATIVELY INFLUENCED BY ANY ABSORBABLE SUTURE. THE DEGRADATION OF THE SUTURE MAY ALSO BE SLIGHTLY ACCELERATED DEPENDING ON THE PATIENT AND THE SEVERITY OF INFECTION." FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE PATIENT INFORMATION DESCRIPTION OF INJURY IF APPLICABLE: THE SYMPTOMS OF INFECTION IN THE WOUND HAS SEEN, SWELLING, REDNESS, SECRETION AND THE WOUND WAS VERY PAINFUL. FROM THE EDGE OF WOUND SOME SKIN HAS UNFASTENED AND SUTURES HAS REMOVED WHEN THE WOUND HAS PARTLY OPENED. THE EDGES HAS BEEN VERY COVERED BY SECRETION. PATIENT OUTCOME: THE WOUND HAS STARTED TO HEAL WHEN THE SUTURE HAS REMOVED AND THE WOUND TREATMENT HAS STARTED. TISSUE WHERE THE SUTURE/MEDICAL DEVICE WAS IMPLANTED OR BEING USED: IN CASE OF SUTURES, TYPE OF SUTURE TECHNIQUE EMPLOYED (CONTINUOUS/INTERRUPTED): SEVERAL INTERRUPTED. IN CASE OF SUTURES, TYPE AND NUMBER OF KNOTS MADE : FIVE STITCHES HAS REMOVED DURING DIFFERENT. ON (B)(6) 2018 STITCHES HAS REMOVED AND THE WOUND HAS OPENED, AFTER THAT THREE PARTS OF SUTURE HAS REMOVED. THE WOUND HAS CLOSED UP VERY SLOWLY AND HAS HEALED (B)(6) 2018. ALL MED WATCH SUBMISSIONS RELATED TO THIS PATIENT ARE: 3003639970-2018-00551.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702069 NOVOSYN SUTURE SUTURES GAM B.BRAUN SURGICAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention