BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 2/0 (3) 70CM HRC26 (M)RCP

    MDR report key: 13756334 · Received March 14, 2022

    Report

    Report Number
    3003639970-2022-00111
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 9, 2022
    Report Date
    May 11, 2022
    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

    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN D4, THE INVOLVED LOT NUMBER NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE: 121151,121275 OR 121494. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE THREE POSSIBLE BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,232 UNITS OF CODE-BATCH 121151. THERE ARE NO UNITS IN OUR STOCK. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 1,908 UNITS OF CODE-BATCH 121275. THERE ARE NO UNITS IN OUR STOCK. WE MANUFACTURED 1,656 UNITS OF CODE-BATCH 121494. THERE ARE 108 UNITS BLOCKED IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FROM THE CUSTOMER. WE HAVE REQUESTED ONE BOX (36 CLOSED SAMPLES) FROM STOCK OF THE BATCH 121494 FOR ANALYSIS. TIGHTNESS TEST TO THE STOCK SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. MONOSYN® BIOCOMPATIBILITY HAS BEEN TESTED IN SEVERAL 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. REVIEWED THE BATCH MANUFACTURING RECORD, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. ACCORDING TO THE RESULTS OF THE SAMPLES TESTED FROM STOCK OF THE BATCH 121494 AND THE BATCH MANUFACTURING RECORDS REVIEW OF THE THREE POSSIBLE BATCHES, THE PRODUCTS COMPLY WITH THE SPECIFICATIONS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCES. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE STOCK SAMPLES RECEIVED FULFIL THE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT A DOG WAS NEUTERED ON (B)(6), 2022 AND CAME TO THE CLINIC ON (B)(6) 2022 DUE TO AN INFLAMMATORY REACTION AT THE SUTURE SITE. ANTIBIOTIC AND ANTI-INFLAMMATORY TREATMENT WAS STARTED WITH NO RESPONSE. ONE WEEK LATER THE ANTI-INFLAMMATORY WAS REPLACED WITH CORTICOSTEROIDS AT ANTI-INFLAMMATORY DOSES AND THERE WAS AN IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971991 MONOSYN VIOLET 2/0 (3) 70CM HRC26 (M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022306 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown