BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN VIOLET 1(4)150CM HRC48 LOOP(M

    MDR report key: 11998191 · Received June 15, 2021

    Report

    Report Number
    3003639970-2021-00224
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    April 29, 2021
    Report Date
    July 14, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE TWO POSSIBLE BATCHES. THE CUSTOMER ALSO INFORMED 119065 BUT DOES NOT EXIST AND NO FURTHER INFORMATION HAS BEEN RECEIVED. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 888 UNITS OF CODE-BATCH 118073. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF CODE-BATCH 119252. THERE ARE NO UNITS IN STOCK OF ANY OF THE POSSIBLE BATCHES. WE HAVE RECEIVED A USED THREAD. FURTHER ANALYSIS CANNOT BE DONE TO THIS THREAD AS IT HAS BEEN USED. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORDS, THE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. PLEASE NOTE THAT NOVOSYN® IS METABOLIZED TO GLYCOLIC ACID AND LACTIC ACID BY HYDROLYSIS WITHOUT CAUSING ANY ENDURING CHANGE IN THE REGION OF THE WOUND. 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. IN CONSEQUENCE, WHEN THE SURGEON RE-OPENED THE WOUND AT DAY 30, LESS THAN 25 % OF THE ORIGINAL TENSILE STRENGTH REMAINED IN THE THREAD. NOVOSYN® SUTURE MATERIALS ARE CONTRA-INDICATED FOR APPLICATIONS WHERE PROLONGED SUPPORT OF THE WOUND CLOSURE BY THE SUTURE MATERIAL IS REQUIRED. MOREOVER, IN THE PRECAUTIONS POINT IN THE INSTRUCTIONS FOR USE OF THE PRODUCT IT IS STATE THAT THE 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. FOR ABDOMINAL WALL CLOSURE MONOMAX IS MORE RECOMMEND. MONOMAX IS A STERILE EXTRA LONG-TERM ABSORBABLE MONOFILAMENT. MONOMAX ABSORBABLE SUTURES ARE INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION WHEN EXTENDED WOUND SUPPORT IS NEEDED (MORE THAN 3 MONTHS) IN ABDOMINAL FASCIAL CLOSURE. 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

    THREE POSSIBLE LOT NUMBERS: 118073,119065,119252. 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 SUTURES. REVISION SURGERY FOR EVISCERATION AT D30 OF A LAPAROTOMY (INTRAPERITONEAL HYPERTHERMIC CHEMOTHERAPY (HIPEC). ON REVISION, ALL FASCIA CLOSURE SUTURES APPEAR TO HAVE BEEN SHEARED ALONG THE SURGICAL EDGES. THE CUSTOMER DOESN'T KNOW WHICH OF THIS POSSIBLE BATCHES IS AFFECTED: 118073-119065-119252. MORE INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894905 NOVOSYN VIOLET 1(4)150CM HRC48 LOOP(M SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. B0068987 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention