BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 2/0 (3) 70CM DS24 (M)

    MDR report key: 8668582 · Received June 4, 2019

    Report

    Report Number
    3003639970-2019-00437
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Report Date
    July 19, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 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. K980704 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 14 UNOPENED POUCHES AND 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 7,308 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. FOR THE ANALYSIS OF BOTH CASES, WE HAVE RECEIVED 14 CLOSED SAMPLES AND 1 OPEN AND USED SAMPLE WITH A PIECE OF THREAD BROKEN. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 4.41 KGF IN AVERAGE AND 4.26 KGF IN MINIMUM (EP REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM) FURTHERMORE, DEGRADATION TEST RESULTS CONDUCTED ON THE CLOSED SAMPLES RECEIVED FULFIL B. BRAUN SURGICAL (BBS) REQUIREMENTS. IN THE DEGRADATION TEST, THREADS ARE INTRODUCED IN A SÖRENSEN SOLUTION AT 37ºC FOR 14 DAYS. AFTER THIS PERIOD, THE KNOT PULL TENSILE STRENGTH OF THE THREAD IS TESTED. THE RESULTS FOR THE CLOSED SAMPLES RECEIVED ARE: 3.42 KGF IN AVERAGE AND 3.02 KGF IN MINIMUM (BBS REQUIREMENTS: 2.26 KFG IN MINIMUM) REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ACCORDING TO THE RESULTS OF THE CLOSED SAMPLES TESTED AND THE BATCH MANUFACTURING RECORD REVIEW, THE PRODUCT COMPLIES THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THREAD BROKE POST- OPERATIVELY. THE REPORTER INDICATED THAT THE THREAD (SUTURE) BROKE ON TWO DIFFERENT DOGS AFTER A HERNIA OF THE ABDOMINAL WALL SURGICAL PROCEDURE WAS PERFORMED. BOTH DOGS HAD THIS SURGERY DURING THE SAME WEEK AND THE ANIMALS WERE KEPT QUIET AFTER THE SURGERY. THE THREAD BROKE 3 AND 4 DAYS AFTER THE OPERATION. A SECOND SURGERY WAS PERFORMED ON BOTH DOGS. THE DOCTOR USED MONOSYN 2/0 FOR THE SECOND OPERATIONS. IT IS REPORTED THE VETERINARIAN HAS USED THIS SUTURE FOR MORE THAN 10 YEARS. THIS REPORT IS FOR THE SECOND DOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461220 SAFIL VIOLET 2/0 (3) 70CM DS24 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1048236 117344

    Patients

    Seq Age Sex Outcome Treatment
    1