BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23756161 · Received December 9, 2025

    Report

    Report Number
    3003639970-2025-00648
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 19, 2025
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    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. UNDER PMA/510(K) NUMBER: K180321. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 NOT RECEIVED ANY SAMPLE FOR THIS CASE. WE RECEIVED A CLOSED SAMPLE FOR ANALYSIS IN ANOTHER COMPLAINT FOLLOWING THIS ONE, RELATED TO THIS CODE-BATCH, FROM THE SAME CUSTOMER AND RELATED TO THE SAME ISSUES. TO EVALUATE THE CONFORMITY OF THIS UNIT, WE PERFORMED THE FOLLOWING TESTS: WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP) FOR AVERAGE: 0.16 KGF IN AVERAGE AND 0.15 KGF IN MINIMUM (EP REQUIREMENTS: 0.17 KGF IN AVERAGE AND 0.082 KGF IN MINIMUM). WE HAVE ALSO TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULT FULFILS THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.39 KGF (EP REQUIREMENTS: 0.15 KGF IN AVERAGE AND 0.06 KGF IN MINIMUM). AS STATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT, WHEN WORKING WITH OPTILENE® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING OR CRIMPING DAMAGE OF THE MONOFILAMENT BY INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND B.BRAUN SURGICAL. CONCLUSION ROOT CAUSE ANALYSIS: REGARDING NEEDLE DETACHMENT DEFECT, THE MOST PROBABLE ROOT CAUSE IS THAT THE ATTACHMENT OF THE NEEDLE WAS NOT CORRECTLY PERFORMED. ON THE OTHER HAND, IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THREAD BREAKAGE DEFECT BECAUSE THE CLOSED SAMPLE RECEIVED COMPLIES USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: CONSIDERING THAT THE SAMPLE RECEIVED DOES NOT FULFIL THE AVERAGE OF THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP) FOR THE NEEDLE ATTACHMENT STRENGTH, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED FOR NEEDLE DETACHMENT DEFECT BY EVIDENCE OF THE FAILURE IN THE SAMPLE RECEIVED. 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 DISSATISFACTION WITH OPTILENE SUTURE MATERIAL. SUTURES TORE WHEN KNOTTING. NEEDLES DETACHED FROM SUTURES. IN ISOLATED CASES, DEFORMATION OR INSTABILITY OF THE NEEDLE-SUTURE CONNECTION. ADDITIONAL INFORMATION: THE SUTURES HAVE BEEN USED IN VASCULAR SURGERY OPERATIONS. THE USER CITED CAROTID SURGERY AS AN EXAMPLE. PATIENT DATA IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007940 OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP OTHER SUTURES GAW B. BRAUN SURGICAL, S.A. C3097175 125253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown