BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 3/0 (2) 90CM 2XHR30 (M)

    MDR report key: 6440794 · Received March 28, 2017

    Report

    Report Number
    3003639970-2017-00157
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Report Date
    May 4, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NEW
    PMA / PMN Number
    K031216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DUE TO THE SUTURES THERE IS STILL LEAKAGE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 6 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND ALL UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL REQUIREMENTS: THE 2.36 KGF IN AVERAGE AND 2.29 KGF IN MINIMUM (REQUIREMENTS: 1.81 KGF IN AVERAGE AND 0.91 KGF IN MINIMUM) DEGRADATION TEST RESULTS CONDUCTED ON THE SAMPLES RECEIVED FULFIL B. BRAUN SURGICAL (BBS) REQUIREMENTS. IN THE DEGRADATION TEST, THREADS ARE INTRODUCED IN SÖRENSEN SOLUTION AT 37ºC FOR 28 DAYS. AFTER THIS PERIOD, THE KNOT PULL TENSILE STRENGTH OF THE THREAD IS TESTED. THE RESULTS FOR THE SAMPLES RECEIVED ARE 1.63 KGF IN AVERAGE AND 1.54 KGF IN MINIMUM (BBS REQUIREMENTS: 1.14 KGF IN AVERAGE AND 0.76 KGF IN MINIMUM). THE LINEAR PULL TENSILE STRENGTH OF THE THREAD HAS ALSO BEEN TESTED AFTER THIS PERIOD (28 DAYS IN SÖRENSEN SOLUTION AT 37ºC), AND THE RESULTS FULFILL B. BRAUN SURGICAL (BBS) REQUIREMENT. THE RESULTS FOR THE SAMPLES RECEIVED ARE 2.46 KGF IN AVERAGE AND 2.23 KGF IN MINIMUM (BBS REQUIREMENT: 1.33 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B.BRAUN SURGICAL REQUIREMENTS. REMARKS: WHEN WORKING WITH MONOPLUS® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN IN ORDER TO ENSURE THAT THE SURGICAL INSTRUMENTS USED, SUCH AS FORCEPS OR NEEDLE HOLDERS DO NOT CAUSE ANY CRUSHING OR CRIMPING DAMAGE TO THE SUTURE MATERIAL. ACCORDING TO THE RESULTS OF THE SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES WITH OUR SPECIFICATIONS AND ALSO FULFILL REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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
    221435 MONOPLUS VIOLET 3/0 (2) 90CM 2XHR30 (M) SUTURES NEW B.BRAUN SURGICAL SA C0024945 115291

    Patients

    Seq Age Sex Outcome Treatment
    1 Other