BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6500389 · Received April 18, 2017

    Report

    Report Number
    3003639970-2017-00197
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 8, 2017
    Report Date
    May 4, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    (B)(6). REACTION TO SUTURE IN ABDOMINAL WALL IN TWO CATS WITH EVENTUATION IN BOTH CASES AND SUBSEQUENT RE-INTERVENTION. ACCORDING TO THE INFORMATION ATTACHED, A VENTRAL HERNIA ACCORD ONE DAY AFTER SURGERY. INTRADERMAL SUTURE AND SUBCUTANEOUS ARE INTACT, THE MUSCULAR LAYER IS OPEN. THE VETERINARIAN REMOVED THE SUTURES AND CLOSED WITH DIFFERENT SUTURES FOR MORE SECURITY. HERNIA OCCURED FIVE DAYS AFTER 2ND SURGERY. INFLAMMATORY REACTION AROUND THE SUTURE, REJECTION TO THE SUTURE AND ADHERED TO EPIPLON.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 27 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. WE HAVE RECEIVED TWO DIFFERENT CASES OF THE SAME BATCH AND FROM THE SAME END CUSTOMER. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED 27 CLOSED SAMPLES FOR ANALYSIS OF BOTH CASES. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF ALL SAMPLES RECEIVED AND THE RESULTS FULFIL REQUIREMENTS: 4.34 KGF IN AVERAGE AND 3.76 KGF IN MINIMUM (REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM) DEGRADATION TEST (14 DAYS IN SÖRENSEN SOLUTION AT 37ºC) HAS BEEN CONDUCTED WITH THE SAMPLES RECEIVED AND THE RESULTS FULFILL B. BRAUN SURGICAL (BBS) REQUIREMENTS (> 0.60 KGF) RESULTS: 1.88 KGF IN MINIMUM AND 2.49 KGF IN AVERAGE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL B.BRAUN SURGICAL REQUIREMENTS. REMARKS: AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT, "WHEN WORKING WITH MONOSYN® 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". ON THE OTHER HAND, MONOSYN BIOCOMPATIBILITY HAS BEEN TESTED IN SEVERAL EXPERIMENTS. IN SENSITIZATION AND IRRITATION TESTS THE HARMLESSNESS OF MONOSYN WAS PROVED. AS INDICATED IN THE MONOSYN INSTRUCTIONS FOR USE (IFU): "WHEN MONOSYN® SUTURE MATERIALS ARE EMPLOYED, THERE IS A MILD INFLAMMATORY REACTION, WHICH IS TYPICAL FOR AN ENDOGENOUS REACTION TO A FOREIGN BODY". THERE ARE RISKS (SIDE EFFECTS) ASSOCIATED TO THE USE OF MONOSYN® SUTURE, WHICH ARE TYPICAL FOR ANY (ABSORBABLE) SUTURE AND WHICH ARE MENTIONED IN THE IFU OF MONOSYN®: "SIDE EFFECTS: AS FOR ALL SUTURES AFTER IMPLANTATION A TRANSIENT INFLAMMATION, TEMPORARY IRRITATION AND INFECTION AT THE WOUND SITE MAY OCCUR OCCASIONALLY. EXISTING INFECTIONS MAY OCCASIONALLY BE ENHANCED BY ANY FOREIGN BODY. AN OCCASIONAL WOUND DEHISCENCE AND GRANULATION MAY NOT BE EXCLUDED." 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282492 MONOSYN VIOLET 2/0 (3) 70CM HR26 (M) SUTURES GAM B.BRAUN SURGICAL SA C0022026 116273

    Patients

    Seq Age Sex Outcome Treatment
    1 Other