BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN VIOLET 2/0 (3) 70CM HR26 (M)

    MDR report key: 8870998 · Received August 7, 2019

    Report

    Report Number
    3003639970-2019-00572
    Event Type
    Injury
    Date Received
    August 7, 2019
    Report Date
    August 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. INVESTIGATION: SAMPLES RECEIVED: 4 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 828 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED FOUR CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 3.89 KGF IN AVERAGE AND 3.73 KGF IN MINIMUM (EP REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM). DEGRADATION TEST RESULTS CONDUCTED ON THE SAMPLES RECEIVED FULFIL B. BRAUN SURGICAL (BBS) REQUIREMENTS AND THE VALUES ARE IN THE USUAL RANGE FOR THIS THREAD AND SIZE. 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 2.98 KGF IN AVERAGE AND 2.79 KGF IN MINIMUM (BBD REQUIREMENT IS 1.42 KGF IN MINIMUM). AS STATED IN THE MODE OF ACTION SECTION IN THE INSTRUCTIONS FOR USE (IFU) OF NOVOSYN: "DURING THE USE OF NOVOSYN® SUTURES A MILD INFLAMMATORY REACTION MAY OCCUR, WHICH IS TYPICAL FOR AN ENDOGENOUS REACTION TO A FOREIGN BODY. 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 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 ADDITION, IN THE NOTE/PRECAUTIONARY MEASURES OF THE IFU ALSO INFORMS: "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 ISSUES 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." WE HAVE CHECKED THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND THERE WAS AN INTERNAL NON CONFORMITY RELATED TO A NON-CONFORMING CONDITIONING PROCESS. AFTER THE REPROCESSING THE PRODUCT THE RESULTS BEFORE RELEASING THE PRODUCT FULFILLED B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE SAMPLES TESTED, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS AND ALSO FULFILL USP/EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. NEVERTHELESS, 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE ARE WOUND HEALING DISTURBANCES. THE REPORTER INDICATED THAT THE SURGEON SOMETIMES HAVE PROBLEMS WITH WOUND HEALING (SUTURE WAS PRESSED OUT OF THE WOUND). PER THE SURGEON, ONE PATIENT WITH WOUND HEALING DISTURBANCES ABOUT 4-6 WEEKS FOLLOWING A CRANIAL PROCEDURE USING INTRA-CUTANEOUS SUTURING TECHNIQUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663323 NOVOSYN VIOLET 2/0 (3) 70CM HR26 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0068042 119107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention