BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 2/0 (3) 70CM HR22 (M)

    MDR report key: 8556187 · Received April 26, 2019

    Report

    Report Number
    3003639970-2019-00380
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Report Date
    May 23, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. INVESTIGATION: SAMPLES RECEIVED: 17 UNOPENED POUCHES TO ANALYZE BOTH PATIENTS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE HAVE RECEIVED TWO DIFFERENT CASES (2 PATIENTS) FROM THE SAME HOSPITAL. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 17 CLOSED SAMPLES TO ANALYZE BOTH CASES. 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): 4.47 KGF IN AVERAGE AND 4.24 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. 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 3.65 KGF IN AVERAGE AND 3.41 KGF IN MINIMUM. B. BRAUN SURGICAL REQUIREMENT IS 2.26 KGF IN MINIMUM. THESE VALUES ARE THE USUAL AND CURRENT ONES FOR THIS THREAD AND SIZE. FOR YOUR INFORMATION, BIOCOMPATIBILITY OF SAFIL® HAS BEEN TESTED IN NUMEROUS EXPERIMENTS. IN SENSIBILISATION AND IRRITATION TESTS THE HARMLESSNESS OF SAFIL® WAS PROVED. AS STATED IN THE INSTRUCTIONS FOR USE (IFU) OF SAFIL MODE OF ACTION: "WHEN SAFIL® SUTURE MATERIALS ARE EMPLOYED THERE IS A MILD INFLAMMATORY REACTION, WHICH IS TYPICAL FOR AN ENDOGENOUS REACTION TO A FOREIGN BODY. AS TIME PASSES THE SUTURE MATERIAL IS ENCAPSULATED BY FIBROUS CONNECTIVE TISSUE. SAFIL® IS METABOLIZED TO GLYCOLIC ACID BY HYDROLYSIS WITHOUT CAUSING ANY ENDURING CHANGE IN THE REGION OF THE WOUND. ABOUT 60 - 70% OF THE ORIGINAL TENSILE STRENGTH REMAINS AFTER 14 DAYS OF IMPLANTATION AND ABOUT 24-42% AFTER 21 DAYS. THE COMPLETE MASS ABSORPTION OF SAFIL® TAKES PLACE AT 60 - 90 DAYS, WHEN THE TISSUE IS NORMALLY PERFUSED." NEVERTHELESS, THERE ARE RISKS (SIDE EFFECTS) ASSOCIATED TO THE USE OF SAFIL® SUTURE, WHICH ARE TYPICAL FOR ANY (ABSORBABLE) SUTURE AND WHICH ARE MENTIONED IN THE IFU OF SAFIL®: "AS FOR ALL SUTURES AFTER IMPLANTATION A TRANSIENT INFLAMMATION, TEMPORARY IRRITATION AND INFECTION AT THE WOUND SITE MAY OCCUR OCCASIONALLY. EXISTING INFECTIONS MAY OCCASIONALLY BE ENHANCED BY ANY FOREIGN BODY. AN OCCASIONAL WOUND DEHISCENCE AND GRANULATION MAY NOT BE EXCLUDED." A REVIEW OF THE BATCH MANUFACTURING RECORD SHOW THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS AND ALSO FULFIL USP/EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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.

    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: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE POSTOPERATIVELY WITH SAFIL; THE PATIENT EXPERIENCED AN INFLAMMATORY REACTION. ON (B)(6) 2019 THE PATIENT UNDERWENT DEBRIDEMENT OF THE RIGHT HALLUX JOINT UNDER LOCAL ANESTHESIA. THE CAPSULE WAS CLOSED WITH SAFIL AND THE SKIN WITH DAFILON. ON THE SAME DAY IN THE EVENING, THE PATIENT HAD AN ELEVATED TEMPERATURE AND SHIVERING WAS NOTED. ON (B)(6) 2019, THE SKIN SUTURE WAS REMOVED AND THERE WAS NO SWELLING OR HEMATOMA VISIBLE. LATER, ON (B)(6) 2019, THE PATIENT COMPLAINED OF PAIN; THERE WAS SWELLING AND REDNESS OVER THE DEEPEST SUTURE PLACEMENTS AND LOCAL SCABBING. ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN ALLERGIC REACTION TO THE SUTURE. A GRANULOMA WAS PRESENT, THE PROXIMAL SPOT WAS SOFT AND "FLUCTUATING". THE INCISION WAS OPENED. UNDER LOCAL ANESTHESIA, HOWEVER, THE SUTURE WAS TOO DEEP TO BE REMOVED. ON (B)(6) 2019, THERE WAS SLIGHT REDNESS AND PAIN BUT THE PATIENT WAS NOTED TO BE RECOVERING. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351025 SAFIL VIOLET 2/0 (3) 70CM HR22 (M) SYNTHETIC ABSORBABLE BRAIDED GAM B.BRAUN SURGICAL SA C1048031 118177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DAFILON - SKIN SUTURE.