BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 45CM HS21

    MDR report key: 9214337 · Received October 21, 2019

    Report

    Report Number
    3003639970-2019-00718
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    October 21, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. K990089. INVESTIGATION: SAMPLES RECEIVED: NO SAMPLES ARE AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 6,480 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLES WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. WE HAVE CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD AND THIS BATCH HAD AN INCIDENCE BUT WAS RELEASED INTO THE MARKET FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS: - KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 1.13 KGF IN AVERAGE AND 1.08 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 0.92 KGF IN AVERAGE AND 0.31 KGF IN MINIMUM) - NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.72 KGF IN AVERAGE AND 0.48 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM). REMARKS: WHEN WORKING WITH SILKAM SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS DO NOT DAMAGE THE MATERIAL BY BEING PINCHED OR KINKED. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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 THE NEEDLE DETACHED AND THREAD BREAKS. THE REPORTER INDICATED THAT A THREAD DETACHED AND ANOTHER THREAD BREAKS DURING SURGERY. NO FURTHER INFORMATION ABOUT THE TYPE OF SEAM IS AVAILABLE. NO PATIENT DATA AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009959 SILKAM BLACK 3/0 (2) 45CM HS21 OTHER SUTURE GAP B.BRAUN SURGICAL SA G0762261 619271

    Patients

    Seq Age Sex Outcome Treatment
    1