BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM DS19

    MDR report key: 17412111 · Received July 28, 2023

    Report

    Report Number
    3003639970-2023-00246
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Report Date
    July 28, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAP
    PMA / PMN Number
    K990089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: 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 59 CLOSED SAMPLES FOR ANALYSIS. WE HAVE CHECKED THE TIPS, EDGES AND GEOMETRY OF THE NEEDLES OF THE SAMPLES RECEIVED AND ARE CONFORM TO THE SPECIFICATION. WE HAVE TESTED THE NEEDLE PENETRATION PERFORMANCE (1ST PENETRATION) OF 10 OF THE NEEDLES RECEIVED AND THE RESULT DOES NOT FULFILL THE SPECIFICATION: 0.543 N IN AVERAGE AND THE MAXIMUM FOR THE 1ST PENETRATION AVERAGE IS 0.480 N. NEEDLE PENETRATION PERFORMANCE (1ST PENETRATION) RESULT OF NEEDLES TESTED DURING PRODUCTION WAS 0.449 N IN AVERAGE AND FULFILLED THE SPECIFICATION (<0.480 N). WE HAVE ALSO TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.31 KGF IN AVERAGE AND 1.21 KGF IN MINIMUM (EP REQUIREMENTS: 0.92 KGF IN AVERAGE AND 0.31 KGF IN MINIMUM) ADDITIONALLY, WE HAVE TESTED THE LINEAR PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS ARE: 1.88 KGF IN AVERAGE AND 1.73 KGF IN MINIMUM, AND THESE RESULTS ARE CORRECT AND USUAL VALUES FOR THIS THREAD AND SIZE. THERE ARE NO EUROPEAN PHARMACOPOEIA AND UNITED STATES PHARMACOPEIA LIMITS FOR THIS TEST. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS REGARDING NEEDLE BLUNT DEFECT, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. 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 SILKAM SUTURE. THE CLIENT REPORTED THAT THE NEEDLES PENETRATE THE SKIN VERY POORLY AND THE SKIN TEARS VERY EASILY. IN ADDITION, THE THREAD BREAKS WHEN THE KNOT IS PULLED DOWN. IT HAPPENED IN THE DERMATOLOGY AND GENERAL SURGERY SERVICES. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966603 SILKAM BLACK 3/0 (2) 75CM DS19 SILK SUTURE GAP B. BRAUN SURGICAL, S.A. C0765210 622373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown