BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    MDR report key: 23756157 · Received December 9, 2025

    Report

    Report Number
    3003639970-2025-00641
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 10, 2025
    Report Date
    January 5, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN AND UNUSED SAMPLE WITH ONE OF THE NEEDLES DETACHED FROM THE THREAD (THREAD IS STILL WOUND ON THE PACK). THE OTHER NEEDLE IS ATTACHED TO THE THREAD. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLE RECEIVED AND THE RESULT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA: 0.139 KGF IN AVERAGE AND IN MINIMUM (EP REQUIREMENTS: 0.082 KGF IN AVERAGE AND 0.041 KGF IN MINIMUM). TAKING INTO ACCOUNT THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS ISSUE FOR THIS CODE-BATCH, WE CONSIDER THAT THIS IS AN ISOLATED UNIT, BUT THE WHOLE BATCH IS CORRECT. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EUROPEAN PHARMACOPOEIA AND B.BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: THE MOST PROBABLE ROOT CAUSE IS THAT THE ATTACHMENT OF THE NEEDLE WAS NOT CORRECTLY PERFORMED. FINAL CONCLUSION: ALTHOUGH THE RESULT OF THE SAMPLE RECEIVED FULFIL EUROPEAN PHARMACOPOEIA/ 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 CLOSED SAMPLE 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. 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 NEEDLE DETACHED INSIDE PACKAGING. BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007936 OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP OTHER SUTURES GAW B. BRAUN SURGICAL, S.A. C3097046 625364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown