BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    MDR report key: 25297962 · Received May 27, 2026

    Report

    Report Number
    3003639970-2026-00534
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 27, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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., K133890. SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 10 CLOSED SAMPLES FOR ANALYSIS. TO EVALUATE THE CONFORMITY OF THESE UNITS, WE PERFORMED THE FOLLOWING TEST: NEEDLE ATTACHMENT STRENGTH RESULTS CONDUCTED ON THE ALL CLOSED SAMPLES RECEIVED ARE 0.41 KGF IN AVERAGE AND 0.283 KGF IN MINIMUM AND FULFIL THE EUROPEAN PHARMACOPOEIA (EP) REQUIREMENTS (EP REQUIREMENTS: 0.17 KGF IN AVERAGE AND 0.082 KGF IN MINIMUM). THESE VALUES ARE IN THE USUAL RANGE FOR THIS THREAD AND SIZE. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE CLOSED SAMPLES RECEIVED COMPLY USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE CLOSED SAMPLES RECEIVED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS; THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE, AND THE CASE IS CONSIDERED NOT CONFIRMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE MEASURES: ACTIONS ON DISTRIBUTED PRODUCT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT DURING THE SUTURING OF A VASCULAR GRAFT USING 6/0 OPTILENE BY DOCTOR THE NEEDLE SEPARATED FROM THE SUTURE MATERIAL IN THE REINFORCEMENT AREA TOWARDS THE END OF THE PROCEDURE. AS A RESULT, THE GRAFT HAD TO BE EXPLANTED. DUE TO THE PREVIOUS SUTURING, THE VENOUS TISSUE WAS IN VERY POOR CONDITION AND HAD TO BE RESECTED FURTHER. THIS LED TO A PROLONGATION OF THE SURGERY BY APPROXIMATELY TWO AND A HALF HOURS. APART FROM THE INCREASED RISK TO THE PATIENT DUE TO THE EXTENDED OPERATING TIME, THE OVERALL COST OF THE PROCEDURE INCREASED. THE CLINIC HAS ALREADY SUBMITTED A PRODUCT COMPLAINT REGARDING THIS ISSUE IN THE PAST. THIS PROBLEM OCCURS MORE FREQUENTLY WITH OPTILENE 6/0, WHILE OTHER SUTURE SIZES ARE NOT AFFECTED. ADDITIONAL INFORMATION RECEIVED OF THE CASE: FEMALE, 84 YEARS OLD. TOWARDS THE END OF THE SUTURE OF THE VASCULAR PROSTHESIS (CONTINUOUS SUTURE TECHNIQUE EMPLOYED), THE NEEDLE IN THE REINFORCEMENT AREA DETACHED FROM THE THREAD. TISSUE SUTURED: VEIN. THE ENTIRE SUTURE HAD TO BE REMOVED AND THE TISSUE WAS RESECTED. SURGERY TAKES AROUND 150 MINUTES. THERE WAS A SIGNIFICANT ANESTHESIA TIME WITH CORRESPONDING RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476018 OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097175 125153

    Patients

    Seq Age Sex Outcome Treatment
    1