BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 8/0 (0,4) 60CM 2XDR6 CV2 RCP

    MDR report key: 24197784 · Received January 28, 2026

    Report

    Report Number
    3003639970-2026-00053
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Report Date
    May 13, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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: K133890. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THE FOLLOWING: ONLY THE NEEDLE BROKE; ONE THREAD BROKE, AND ANOTHER THREAD DETACHED FROM THE NEEDLE AS SOON AS IT WAS REMOVED FROM THE RACE-PACK. THE JUNCTION BETWEEN THE THREAD AND THE NEEDLE IS NOT SMOOTH BUT HAS BURRS, MAKING IT DIFFICULT TO PULL THE NEEDLE DURING STITCHING AND CAUSING THE THREAD TO FRAY/SPLIT. THE THREAD SPLIT INTO TWO STRANDS. PACKAGING ERROR: THE THREAD IS CAUGHT IN THE SEALING OF OUTER PACKAGE, AND WAS NOT SECURED IN THE RACEPACK (INNER PACKAGE). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469564 OPTILENE 8/0 (0,4) 60CM 2XDR6 CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097712 124471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown