BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON 3/0 (2) 100M

    MDR report key: 22563158 · Received July 22, 2025

    Report

    Report Number
    3003639970-2025-00393
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Report Date
    July 22, 2025
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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., K151165. 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 3 OPEN SAMPLES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.59 KGF IN AVERAGE AND 1.29 KGF IN MINIMUM (EP REQUIREMENTS: 0.51 KGF IN AVERAGE AND 0.15 KGF IN MINIMUM). 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 SAMPLES RECEIVED COMPLY USP/EP AND B. BRAUN SURGICAL REQUIREMENTS FOR KNOT PULL TENSILE STRENGTH. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF 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 SAMPLES 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 DAFILON SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT HAS 3 FLAT SPOOLS WHERE THE THREAD CONSTANTLY BREAKS. WHEN CUSTOMER PULLED THE THREAD OUT OF THE SPOOL DURING AN OPERATION, HE FELT THAT THE TENSION OF THE THREAD HAD ALREADY CHANGED. WHEN HE TRIED TO TEAR THE THREAD, HE SUCCEEDED WITHOUT ANY DIFFICULTY (NORMALLY IT IS IMPOSSIBLE TO TEAR A SURGICAL SUTURE). AFTER THE THREAD HAD BROKEN, HE UNPACKED 2 MORE SPOOLS THAT WERE STILL IN THEIR ORIGINAL PACKAGING AND THESE THREADS WERE ALSO BRITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293679 DAFILON 3/0 (2) 100M OTHER SUTURES GAR B. BRAUN SURGICAL, S.A. F1934040 624306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown