BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M)

    MDR report key: 8555180 · Received April 26, 2019

    Report

    Report Number
    3003639970-2019-00376
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Report Date
    May 21, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. INVESTIGATION: SAMPLES RECEIVED: 6 UNOPENED POUCHES. 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 SIX CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. SEWING TEST ON ARTIFICIAL SKIN TISSUE HAS BEEN CONDUCTED WITH THE SAMPLES RECEIVED AND CORE POPPING APPEARS IN SOME UNITS WHEN PULLING THE THREAD THROUGH THE TISSUE. THE STRUCTURE OF MULTIFILAMENT THREADS IN THE MOST NOVOSYN SIZES IS COMPOSED BY A CORE OF FIBERS (INTERNAL PART) AND A COVER OF BRAIDING FIBERS (EXTERNAL PART). PUNCTUALLY, IN THE BRAIDING PROCESS THERE MAY BE LITTLE TENSION DIFFERENCES BETWEEN THE CORE AND THE COVER FIBERS AND IT COULD CAUSE THAT THE COVER FIBERS COME OUT FROM THE BRAIDING (CORE-POPPING). A REVIEW OF THE BATCH MANUFACTURING RECORD FOR THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. 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 · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NOVOSYN. DURING A PROCEDURE TO TREAT CROHN'S DISEASE, THE SUTURE WAS NOTED TO CURL. THIS OCCURRED AFTER CONTACT WITH TISSUE; THE UPPER LAYER BECAME DETACHED AND FRIZZY, AND THE CORE SEEMED TO BE "POPPING". THE SURGEON SUSPECTED IT WAS A POTENTIAL CHEMICAL REACTION BETWEEN THE SUTURE AND BOWEL TISSUE. THERE WAS NO PATIENT INJURY AND THE SURGERY WAS A BIT PROLONGED DUE TO OPENING A DIFFERENT SUTURE. A PICTURE WAS RECEIVED WHICH SHOWED THE TWISTING/MALFUNCTION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349050 NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M) SYNTHETIC ABSORBABLE BRAIDE GAM B.BRAUN SURGICAL SA C0068041 119027

    Patients

    Seq Age Sex Outcome Treatment
    1