BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 5/0 (1) 45CM DS16 (M)

    MDR report key: 18037879 · Received October 31, 2023

    Report

    Report Number
    3003639970-2023-00337
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    July 1, 2021
    Report Date
    November 13, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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. RELATED 510K NUMBER K122734. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: ACCORDING TO THE INFORMATION AVAILABLE EXACT BATCH NUMBER IS UNKNOWN. FOUR BATCHES SUPPLIED TO B. BRAUN CHINA SINCE 2021: 121021, 121235, 121143 AND 121284. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE POSSIBLE BATCHES. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE OF ANY OF THE BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF BATCH 121021;(B)(4) UNITS OF BATCH 121235; (B)(4) UNITS OF BATCH 121143; (B)(4) UNITS OF BATCH 121284. WE HAVE NOT RECEIVED ANY SAMPLES. WITHOUT CLOSED AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORDS OF THE POSSIBLE BATCHES, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL 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 AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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 SAFIL SUTURE. THE CLIENT REPORTED THAT PERFORMED A CESAREAN SECTION ON (B)(6) 2021. WHEN CLOSING THE SKIN WITH THIS PRODUCT, IT WAS FOUND THAT THE NEEDLE AND THREAD WERE SEPARATED. THE CIRCULATING NURSE REPLACED A NEW ONE. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223097 SAFIL VIOLET 5/0 (1) 45CM DS16 (M) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C1048212

    Patients

    Seq Age Sex Outcome Treatment
    1 Female