BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 6/0 (0.7) 60CM 2XDR12 (M)CV

    MDR report key: 8781304 · Received July 11, 2019

    Report

    Report Number
    3003639970-2019-00531
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 1, 2019
    Report Date
    August 26, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: 1 UNOPENED RACE PACK. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED ONE CLOSED SAMPLE FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULT FULFILS THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.31 KGF (EP REQUIREMENTS: 0.15 KGF IN AVERAGE AND 0.06 KGF IN MINIMUM) WE HAVE ALSO CHECKED THE SAMPLE RECEIVED BEFORE AND AFTER PERFORMING THE TEST AND NO DEFECTS HAVE BEEN FOUND ON THE THREAD SURFACE. AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT, 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 THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED. ADDITIONALLY, WE HAVE CONDUCTED A REVIEW OF THE COMPLAINT HISTORY RECORD AND THERE ARE NO OTHER COMPLAINTS RECEIVED OF THE PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCH AS THE COMPLAINED PRODUCT. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE SAMPLE TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS AND ALSO FULFILL USP/EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K980703. WHEN ADDITIONAL INFORMATION IS PROVIDED A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SUTURE DISINTEGRATED. IT WAS REPORTED ON (B)(6) 2019 AN ILIOFEMORAL BYPASS OPERATION WAS PERFORMED WITH SUTURE MATERIAL PREMILENE 6/0 REF (B)(4), PREMILENE 5/REF (B)(4) TO FIX THE PROSTHESIS. ON (B)(6) 2019 THE PATIENT CONDITION WORSENED AND DURING FOLLOWING RE-OPERATION OF ENDARTERECTOMY THE SURGEON FOUND DISINTEGRATED SUTURE. PATIENT OUTCOME UNKNOWN. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573866 PREMILENE 6/0 (0.7) 60CM 2XDR12 (M)CV CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C2090705 117492

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention