BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 17779504 · Received September 20, 2023

    Report

    Report Number
    3003639970-2023-00314
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 9, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: WE HAVE RECEIVED 4 CASES FROM THE SAME CUSTOMER, AT THE SAME TIME, 3 OF THEM REGARDING SIMILAR ISSUES, FROM 2 CODES AND 3 BATCHES. ACCORDING TO THE INFORMATION RECEIVED FROM CUSTOMER, WE WILL TAKE INTO ACCOUNT ALL THE POSSIBLE CODE-BATCHES RECEIVED IN ALL CASES. THERE ARE NO PREVIOUS COMPLAINTS NOR UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE OF THESE CODES-BATCHES. (B)(4) UNITS OF THE CODE BATCH C2022242-122121, (B)(4) UNITS OF THE CODE BATCH C2022242-121473 AND (B)(4) UNITS OF THE CODE BATCH C2022053-122374 WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. WE HAVE RECEIVED 1 CLOSED SAMPLE OF THE CODE BATCH C2022242-122121, 1 CLOSED AND 1 OPEN SAMPLES OF THE CODE BATCH C2022242-121473 AND 4 CLOSED SAMPLES OF THE CODE BATCH C2022053-122374, TO ANALYZE THESE CASES. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAVE BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM): 4.27 KGF OF THE CODE BATCH C2022242-122121, 5.08 KGF OF THE CODE BATCH C2022242-122473 AND 4.76 KGF IN AVERAGE AND 4.26 KGF IN MINIMUM OF THE CODE BATCH C2022053-122374. DEGRADATION TEST RESULTS CONDUCTED WITH THE CLOSED SAMPLES RECEIVED AT 37ºC INTO SÖRENSEN SOLUTION AFTER 14 DAYS ARE 3.61 KGF OF THE CODE BATCH C2022242-122121, 3.67 KGF OF THE CODE BATCH C2022242-122473 AND 2.92 KGF IN AVERAGE AND 2.53 KGF IN MINIMUM OF THE CODE BATCH C2022053-122374 AND FULFILL B. BRAUN SURGICAL REQUIREMENT: 0.60 KGF IN MINIMUM. THESE VALUES ARE IN THE USUAL RANGE FOR THESE THREADS AND SIZES. REVIEWED THE BATCH MANUFACTURING RECORDS, THE CODE BATCHES C2022242-122121 AND 122473 HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. THE CODE-BATCH C2022053-122374 HAD AN INCIDENCE BUT WAS RELEASED INTO THE MARKET FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. WE HAVE ALSO REVIEWED THE COMPLAINT HISTORY RECORD, AND THERE ARE NO PREVIOUS COMPLAINTS IN ANY OF THE OTHER PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCHES USED IN THE POSSIBLE PRODUCTS INVOLVED. AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: WHEN WORKING WITH MONOSYN® SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING AND CRIMPING DAMAGE OF THE MONOFILAMENT BY SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS. MONOSYN BIOCOMPATIBILITY HAS BEEN TESTED IN NUMEROUS EXPERIMENTS. IN SENSITIZATION AND IRRITATION TESTS THE HARMLESSNESS OF MONOSYN WAS PROVED. NEVERTHELESS, AS STATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT, AS FOR ANY SUTURES AFTER IMPLANTATION THE FOLLOWING SIDE EFFECTS MAY OCCUR OCCASIONALLY: TRANSIENT INFLAMMATION FOREIGN BODY REACTION, TRANSITORY LOCAL IRRITATION, GRANULATION, STITCH ABSCESS OR SINUS, IMPAIRED COSMETIC RESULT AND INFECTION AT THE WOUND SITE. EXISTING INFECTIONS MAY OCCASIONALLY BE ENHANCED BY ANY FOREIGN BODY. MAY NOT BE EXCLUDED AN OCCASIONAL WOUND DEHISCENCE, SUTURE EXTRUSION, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN CLOSURE OF THE SITES WHERE EXPANSION, STRETCHING OR DISTENSION OCCUR, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN ELDERLY, MALNOURISHED OR DEBILITATED PATIENTS OR IN PATIENTS SUFFERING FROM CONDITIONS WHICH MAY DELAY WOUND HEALING AND/OR DELAYED ABSORPTION IN TISSUE WITH POOR BLOOD SUPPLY. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THESE INCIDENCES IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASES ARE CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE CLOSED 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. 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.

    Additional Manufacturer Narrative · 0

    THE INVOLVED ARTICLE CODE-BATCH IS NOT KNOWN. THE POSSIBLE PRODUCTS INVOLVED ARE: D1: BRAND NAME: MONOSYN VIOLET 2/0 (3) 90CM HS26S(M)RCP OR MONOSYN VIOLET 2/0 (3) 70CM HS26S (M)RCP. D4: MODEL AND CATALOG NUMBER: C2022053 OR C2022242; LOT NUMBERS: 122374 (FOR THE MODEL NUMBER C2022053) OR 121473 OR 122121 (FOR DE MODEL NUMBER (C2022242). G4: PMA/510(K) NUMBER: FOR THE MODEL NUMBER C2022053, 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., (K011375). FOR THE MODEL NUMBER C2022242, K011375. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT A 10 YEARS OLD DOG, AFTER A GASTROSTOMY OPERATION, HAS COMPLICATIONS SUCH AS SUTURE DEHISCENCE, ABSCESS, INFECTION AND NECROSIS. IT OCCURRED 3 DAYS AFTER THE OPERATION. THE SUTURE IS SUSPECTED. THREE SIMILAR CASES HAVE BEEN RECEIVED FROM THE SAME HOSPITAL. THE MFR REPORT NUMBERS ARE: 3003639970-2023-00313; 3003639970-2023-00315.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059308 SEE H10 SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown