BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN

    MDR report key: 11883096 · Received May 26, 2021

    Report

    Report Number
    3003639970-2021-00176
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 21, 2021
    Report Date
    November 12, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THE CUSTOMER DOES NOT KNOW THE EXACT REFERENCE USED FOR EACH PATIENT. FOUR POSSIBLE REFERENCES C0068251, C0069431, C0069294 AND C0068496. LIST OF BATCHES OF THE REFERENCE C0068251 SUPPLIED TO THE CUSTOMER: 720396,720426 AND 721022. LIST OF BATCHES OF THE C0069431 REFERENCE SUPPLIED TO THE END CUSTOMER: 720461 AND 720386. LIST OF BATCHES OF THE C0069294 REFERENCE SUPPLIED TO THE END CUSTOMER: 721026, 720482 AND 720371. LIST OF BATCHES OF C0068496 REFERENCE SUPPLIED TO THE CUSTOMER: 121034, 120514, 120493, 120296, 120295 AND 720294. FOR REFERENCE C0068251, THERE IS A PREVIOUS COMPLAINT, IN THE LAST FIVE YEARS AND INVOLVING NEEDLE DETACHMENT. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 720396; (B)(4) UNITS OF BATCH 720426 AND (B)(4) UNITS OF BATCH 721022 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. FOR REFERENCE C0069431 THERE ARE NO PREVIOUS COMPLAINTS, IN THE LAST FIVE YEARS. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 720461 AND (B)(4) UNITS OF BATCH 720386 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. FOR REFERENCE C0069294, THERE ARE NO PREVIOUS COMPLAINTS, IN THE LAST FIVE YEARS. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 720371; (B)(4) UNITS OF BATCH 720482 AND (B)(4) UNITS OF BATCH 721026 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. FOR REFERENCE C0068496, THERE ARE TWO PREVIOUS COMPLAINTS, IN THE LAST FIVE YEARS, REGARDING SEROMAS 2-3 DAYS AFTER SURGERY THAT WERE CLOSED AS NOT CONFIRMED. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 120295; (B)(4) UNITS OF BATCH 120296; (B)(4) UNITS OF BATCH 120493; (B)(4) UNITS OF BATCH 120514; (B)(4) UNITS OF BATCH 121034 AND (B)(4) UNITS OF BATCH 720294 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. ACCORDING TO THE INFORMATION RECEIVED FOR PATIENT 1, THERE WAS NO INFECTION IN THE WOUND, THE SKIN IS WELL HEALED INTERNALLY BUT EXTERNALLY THERE IS DISUNITY OF THE WOUND. THIS WAS FOUND 6 WEEKS AFTER THE SURGERY. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. STERILITY TEST HAS BEEN PERFORMED TO 10 OF THE UNITS OF EACH BATCH. 10 REPLICATES WERE INTRODUCED INTO BOTTLES WITH TRYPTIC SOY BROTH (TSB) MEDIUM IN STERILE CONDITIONS. THE BOTTLES WERE INCUBATED FOR 7 DAYS AT 20 ºC - 25 ºC AND ANOTHER 7 DAYS AT 30 ºC - 35 ºC TO VERIFY THEIR STERILITY. ALL TESTED REPLICATES FULFIL THE STERILITY TEST AFTER 14 DAYS OF INCUBATION IN TSB MEDIUM, AS ALL BOTTLES REMAINED ABSENT OF TURBIDITY. THE ANALYZED SAMPLES FULFIL THE SPECIFICATIONS FOR THE STERILITY TEST. ADDITIONALLY, DEGRADATION TEST RESULTS CONDUCTED ON THE SAMPLES RECEIVED 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 SAMPLES RECEIVED ARE: CODE-BATCH C0068496-121063: 3.42 KGF IN AVERAGE AND 3.28 KGF IN MINIMUM (BBS REQUIREMENT: 2.07 KGF IN MINIMUM). CODE-BATCH C0068496-120296: 3.62 KGF IN AVERAGE AND 3.42 KGF IN MINIMUM (BBS REQUIREMENT: 2.07 KGF IN MINIMUM). CODE-BATCH C0068251-720426: 2.74 KGF IN AVERAGE AND 2.59 KGF IN MINIMUM (BBS REQUIREMENT: 1.42 KGF IN MINIMUM). CODE-BATCH B0068463-721084: 6.14 KGF IN AVERAGE AND 5.72 KGF IN MINIMUM (BBS REQUIREMENT: 3.36 KGF IN MINIMUM). CODE-BATCH B0068488-721046: 6.04 KGF IN AVERAGE AND 5.62 KGF IN MINIMUM (BBS REQUIREMENT: 3.36 KGF IN MINIMUM). THESE VALUES ARE IN THE USUAL RANGE FOR THIS THREAD AND SIZE. IN THE INSTRUCTIONS FOR USE OF THE PRODUCT IT IS STATED THAT "SKIN SUTURES WHICH REMAIN IN PLACE LONGER THAN 7 DAYS MAY CAUSE LOCALIZED IRRITATION AND SHOULD BE SNIPPED OFF OR REMOVED AS INDICATED." REGARDING THE DEGRADATION PROFILE: "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." IT IS ALSO STATED: 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." AND IN THE SIDE EFFECTS AREA: "THE FOLLOWING SIDE EFFECTS MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT: PAIN, GRANULOMA, SEROMA, HEMATOMA, REJECTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, ANASTOMOTIC LEAK AND HAEMORRHAGE." 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. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE 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. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THE CUSTOMER DOES NOT KNOW THE EXACT REFERENCE USED FOR EACH PATIENT. FOUR POSSIBLE REFERENCES C0068251, C0069431, C0069294 AND C0068496. LIST OF BATCHES OF THE REFERENCE C0068251 SUPPLIED TO THE CUSTOMER: 720396,720426 AND 721022. LIST OF BATCHES OF THE C0069431 REFERENCE SUPPLIED TO THE END CUSTOMER: 720461 AND 720386. LIST OF BATCHES OF THE C0069294 REFERENCE SUPPLIED TO THE END CUSTOMER: 721026, 720482 AND 720371. LIST OF BATCHES OF C0068496 REFERENCE SUPPLIED TO THE CUSTOMER: 121034, 120514, 120493, 120296, 120295 AND 720294. FOR REFERENCE C0068251, THERE IS A PREVIOUS COMPLAINT, IN THE LAST FIVE YEARS AND INVOLVING NEEDLE DETACHMENT. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 720396; (B)(4) UNITS OF BATCH 720426 AND (B)(4) UNITS OF BATCH 721022 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. FOR REFERENCE C0069431 THERE ARE NO PREVIOUS COMPLAINTS, IN THE LAST FIVE YEARS. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 720461 AND (B)(4) UNITS OF BATCH 720386 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. FOR REFERENCE C0069294, THERE ARE NO PREVIOUS COMPLAINTS, IN THE LAST FIVE YEARS. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 720371; (B)(4) UNITS OF BATCH 720482 AND 432 UNITS OF BATCH 721026 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. FOR REFERENCE C0068496, THERE ARE TWO PREVIOUS COMPLAINTS, IN THE LAST FIVE YEARS, REGARDING SEROMAS 2-3 DAYS AFTER SURGERY THAT WERE CLOSED AS NOT CONFIRMED. THERE ARE NO COMPLAINTS FOR ANY OF THE POSSIBLE BATCHES OF THIS REFERENCE. (B)(4) UNITS OF BATCH 120295; (B)(4) UNITS OF BATCH 120296; (B)(4) UNITS OF BATCH 120493; (B)(4) UNITS OF BATCH 120514; (B)(4) UNITS OF BATCH 121034 AND (B)(4) UNITS OF BATCH 720294 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. ACCORDING TO THE INFORMATION RECEIVED FOR PATIENT 1, THERE WAS NO INFECTION IN THE WOUND, THE SKIN IS WELL HEALED INTERNALLY BUT EXTERNALLY THERE IS DISUNITY OF THE WOUND. THIS WAS FOUND 6 WEEKS AFTER THE SURGERY. WITHOUT SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. IN THE INSTRUCTIONS FOR USE OF THE PRODUCT IT IS STATED THAT "SKIN SUTURES WHICH REMAIN IN PLACE LONGER THAN 7 DAYS MAY CAUSE LOCALIZED IRRITATION AND SHOULD BE SNIPPED OFF OR REMOVED AS INDICATED." REGARDING THE DEGRADATION PROFILE: " 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." IT IS ALSO STATED: 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." AND IN THE SIDE EFFECTS AREA: "THE FOLLOWING SIDE EFFECTS MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT: PAIN, GRANULOMA, SEROMA, HEMATOMA, REJECTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, ANASTOMOTIC LEAK AND HAEMORRHAGE." WITH THE INFORMATION RECEIVED AND THE BATCH MANUFACTURING RECORDS REVIEW AND HISTORICAL DATA REVIEW WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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 ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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.

    Additional Manufacturer Narrative · 1

    THE POSSIBLE PRODUCT REFERENCES INVOLVED ARE C0068251, C0069431, C0069294, C0068496. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CUSTOMER REPORTED POST-OPERATIVE APPEARANCE OF MICRO-ABSCESSES AND/OR SUBCUTANEOUS GRANULOMAS FOLLOWING SUBCUTANEOUS SUTURES IN 10 PATIENTS. SIGNIFICANT INCREASE IN INCIDENCE FOLLOWING A CHANGE OF MARKET FROM THE OPTIME RANGE OF PETERS SURGICAL TO THE NOVOSYN RANGE OF BBRAUN. THE CLINICAL CONSEQUENCES WERE: LOCAL NOSOCOMIAL INFECTIONS, 6 PATIENTS WERE TAKEN BACK TO THE SURGICAL UNIT FOR EXCISION OF THE LESION, THERE WERE NO SERIOUS CLINICAL CONSEQUENCES FOR THE PATIENT BUT SIGNIFICANT INCREASE IN THE RISK OF INFECTION, POSSIBLE RISK OF INFECTION ON PROSTHESIS AND/OR OSTEOSYNTHESIS, RESUMPTION IN THE SURGICAL SUITE PREJUDICIAL TO THE PATIENT AND THE DEPARTMENT, INCREASED HEALING TIME AND POSSIBLE AESTHETIC DEFECT PREJUDICIAL TO THE PATIENT. NO SAMPLES WERE KEPT AND THE POSSIBLE PRODUCT REFERENCES INVOLVED ARE C0068251, C0069431, C0069294, C0068496. ALL MEDWATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2021-00177, 3003639970-2021-00178, 3003639970-2021-00179, 3003639970-2021-00206, 3003639970-2021-00207, 3003639970-2021-00208, 3003639970-2021-00209, 3003639970-2021-00210, 3003639970-2021-00211. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784441 NOVOSYN SYNTHETIC ABSORBABLE BRAIDED SUTURES GAM B. BRAUN SURGICAL, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention