BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 5 (7) 140CM HRT48 (M)E-SET

    MDR report key: 8605705 · Received May 13, 2019

    Report

    Report Number
    3003639970-2019-00402
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 10, 2019
    Report Date
    December 16, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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. K031286. (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: NO SAMPLES AVAILABLE FOR ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE SAMPLES WERE NOT CLEARED BY CUSTOMS IN SPAIN AND COULD BE SENT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE HAVE RECEIVED FOUR DIFFERENT CASES FROM THE SAME CUSTOMER. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. 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: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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

    INVESTIGATION: SAMPLES RECEIVED: 2 UNOPENED POUCHES TO ANALYZE THE 4 CASES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE HAVE RECEIVED 4 DIFFERENT CASES FROM THE SAME END CUSTOMER REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. 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. WE HAVE RECEIVED TWO CLOSED SAMPLES TO ANALYZE THE FOUR CASES. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE CLOSED SAMPLES FOR: KNOT PULL TENSILE STRENGTH AND THE RESULTS FULFIL THE REQUIREMENTS OF B. BRAUN SURGICAL (BBS): 14.56 KGF IN AVERAGE AND 13.94 KGF IN MINIMUM (BBS REQUIREMENTS: 8.79 KGF IN AVERAGE AND 4.39 KGF IN MINIMUM). DEGRADATION TEST AND THE RESULTS FULFIL B. BRAUN SURGICAL (BBS) REQUIREMENTS. IN THE DEGRADATION TEST, THREADS ARE INTRODUCED IN A 0.9 % NACL 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 12.04 KGF IN AVERAGE AND 11.75 KGF IN MINIMUM (B. BRAUN SURGICAL REQUIREMENT IS 8.79 KGF IN MINIMUM). ACCORDING TO THE RESULTS OF THE TESTS REALIZED TO THE CLOSED SAMPLES RECEIVED FROM THE CUSTOMER AND THE BATCH MANUFACTURING RECORDS REVIEW, THE PRODUCTS COMPLY WITH OUR SPECIFICATIONS; THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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. ASSOCIATED MEDWATCHES: 3003639970-2019-00403, 3003639970-2019-00404, AND 3003639970-2019-00405.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUTURE IS BREAKING. IT WAS REPORTED THAT THE VETERINARIAN CLOSED THE LINEA ALBA USING A SURGEONS KNOT PLUS 3 SQUARE KNOTS MADE AT THE START AND THE END OF SUTURING. THE HORSE RECEIVED DEXAMETHASONE FOR A WEEK POST OPERATIVELY. THE SUTURE MATERIAL BROKE 20 DAYS POST OPERATIVELY CAUSING EVISCERATION. THE SUTURE FAILURE OCCURRED BETWEEN THE CRANIAL AND MIDDLE THIRD OF THE CONTINUOUS PATTERN. THE SUTURE MATERIAL SNAPPED AT THE END BUT NOT AT THE KNOTS. THE ANIMAL WAS EUTHANIZED BECAUSE OF COMPLETE EVISCERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399248 SAFIL VIOLET 5 (7) 140CM HRT48 (M)E-SET SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA G1048515 118193

    Patients

    Seq Age Sex Outcome Treatment
    1