BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET7/0(0.5)45CM2XDLM6S200M

    MDR report key: 18473167 · Received January 9, 2024

    Report

    Report Number
    3003639970-2024-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Report Date
    February 1, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: WE HAVE RECEIVED A COMPLAINT OF THE SAME CUSTOMER WITH THE SAME CODE AND 4 DIFFERENT BATCHES. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE CODE-BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE BATCH 123083, (B)(4) UNITS OF THE BATCH 123272, (B)(4) UNITS OF THE BATCH 123202 AND (B)(4) UNITS OF THE BATCH 123361. THERE ARE NO UNITS IN OUR STOCK OF ANY OF THE BATCHES. WE HAVE RECEIVED 2 CLOSED SAMPLES OF EACH BATCH (8 CLOSED SAMPLES IN TOTAL). TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. COLOUR AND BRAIDING OF THE CLOSED SAMPLES RECEIVED IS CORRECT. SEWING TEST ON ARTIFICIAL SKIN TISSUE HAS BEEN CONDUCTED WITH THE CLOSED SAMPLES RECEIVED AND VISUAL APPEARANCE IS THE USUAL ONE. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORDS, ALL POSSIBLE CODE-BATCHES HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EUROPEAN PHARMACOPOEIA AND B.BRAUN SURGICAL REQUIREMENTS. AS STATED IN THE SIDE EFFECTS OF THE INSTRUCTION FOR USE OF THE PRODUCT, "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." CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE CLOSED SAMPLES RECEIVED COMPLY B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. CORRECTIVE MEASURES: 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. YOU WILL RECEIVE A CREDIT NOTE FOR THE PRODUCT SENT FOR ANALYSIS AS COMPENSATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CLIENT REPORTED THAT USED IN OPHTHALMOLOGY THEY HAVE NOTICED DIFFERENCES IN THE COLOR AND BRAIDING OF THE SUTURE, AS WELL AS GREATER GRANULATION IN THE CONJUNCTIVA, RIGHT AT THE SITE OF THE STITCH. NO FURTHER INFORMATION HAS BEEN RECEIVED BUT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553233 NOVOSYN VIOLET7/0(0.5)45CM2XDLM6S200M SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. G0068711

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown