BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)45CM HS23(M)DDP

    MDR report key: 10262546 · Received July 13, 2020

    Report

    Report Number
    3003639970-2020-00254
    Event Type
    Injury
    Date Received
    July 13, 2020
    Report Date
    August 3, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME REFERENCE-BATCH. WE HAVE RECEIVED A TOTAL OF (B)(4) CASES FROM THE SAME HOSPITAL INVOLVING THIS CODE-BATCH AND REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. 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 (B)(4) CLOSED SAMPLES OF THIS CODE-BATCH TO ANALYZE THE (B)(4) CASES. WE HAVE CHECKED THESE SAMPLES AND NO DEFECTS HAVE BEEN FOUND. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE PERFORMED THE STERILITY TEST IN THE THREAD OF THE SAMPLES RECEIVED AND THE SAMPLES INCUBATED FOR 14 DAYS REMAINED WITHOUT MICROBIAL GROWTH. THEREFORE, THE SAMPLES COMPLY WITH THE STERILITY TEST. AS STATED IN THE SIDE EFFECTS OF THE INSTRUCTIONS FOR USE OF THE PRODUCT, THE FOLLOWING SIDE EFFECTS MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT: TRANSITORY LOCAL IRRITATION, TRANSIENT INFLAMMATORY FOREIGN BODY REACTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, GRANULATION. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, 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. 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. THE OTHER 11 CASES ARE REPORTED UNDER MFR REPORT NUMBER: 3003639970-2020-00244, 3003639970-2020-00245, 3003639970-2020-00246, 3003639970-2020-00247, 3003639970-2020-00248, 3003639970-2020-00249, 3003639970-2020-00250, 3003639970-2020-00251, 3003639970-2020-00252, 3003639970-2020-00253, 3003639970-2020-00255.

    Additional Manufacturer Narrative · 1

    K170661. 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NOVOSYN QUICK SUTURE. THE CUSTOMER REPORTED THAT THEY ARE USING NOVOSYN QUICK SUTURE SINCE (B)(6) 2020 AND SINCE THEN 12 CASES OF WOUND NON-HEALING PER PRIMAM WERE FOUND. THE PATIENTS HAD TO BE REOPERATED AND HEALING PER SECUNDAM. THE TYPE OF SURGERY WAS A TOTAL THYROIDECTOMY AND TISSUES ON HEAD AND NECK AREA. THIS SUTURE WAS USED ON SUBCUTANEOUS SUTURE AND TWO TO THREE STITCHES DONE. SUBSEQUENTLY, SMEARS WERE PERFORMED BY HOSPITAL HYGIENIST. THE HOSPITAL SENT TWO PIECES OF SUTURE MATERIAL FOR MICROBIOLOGICAL EXAMINATION. THE RESULTS IN THESE SAMPLES WERE UNSATISFACTORY DUE TO THE PRESENCE OF A NON-PATHOGENIC MICROORGANISM ON THE DISCARDED SUTURE MATERIAL. ACCORDING TO THE INFORMATION RECEIVED, THE HOSPITAL CAN NOT PROVIDE ADDITIONAL INFORMATION OF EACH CASE. THIS REPORT CORRESPONDS TO THE PATIENT 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729626 NOVOSYN QUICK UNDY 3/0(2)45CM HS23(M)DDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C3046230 119394

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention