BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 2/0 (3) 10X45CM

    MDR report key: 9161785 · Received October 7, 2019

    Report

    Report Number
    3003639970-2019-00686
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Report Date
    October 7, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. K031286. INVESTIGATION: SAMPLES RECEIVED: 23 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 1,800 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 23 UNOPENED POUCHES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPEIA (EP): 2.20 KGF IN AVERAGE AND 2.11 KGF IN MINIMUM (EP REQUIREMENTS: 1.53 KGF IN AVERAGE AND 0.92 KGF IN MINIMUM). 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. REMARKS: WHEN WORKING WITH SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS, DOES NOT CAUSE THREAD DAMAGE. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE BROKE DURING SURGERY. THE REPORTER INDICATED DURING A SURGICAL PROCEDURE, THE THREAD BRAKES DURING HANDLING. IT HAS OCCURRED IN GENERAL SURGERY SERVICE. THERE IS NO PATIENT DATA AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955560 SILKAM BLACK 2/0 (3) 10X45CM OTHER SUTURE GAP B.BRAUN SURGICAL SA C0266663 617432

    Patients

    Seq Age Sex Outcome Treatment
    1