BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN UNDYED 2/0 (3) 70CM DS24 (M)RCP

    MDR report key: 14953632 · Received July 8, 2022

    Report

    Report Number
    3003639970-2022-00278
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 8, 2022
    Report Date
    August 18, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. UNDER PMA/510(K) NUMBER: K122734. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE THREE PREVIOUS COMPLAINTS OF THIS CODE-BATCH REGARDING THIS ISSUE, ONE OF THEM CLOSED AS CONFIRMED AFTER ANALYSIS. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 7,632 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED SAMPLES FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. HOWEVER, TAKING INTO ACCOUNT THAT THERE IS A PREVIOUS CONFIRMED COMPLAINT OF THE SAME CODE-BATCH REGARDING THIS ISSUE, WE CONSIDER THIS CASE CONFIRMED AS WELL. REVIEWED THE BATCH MANUFACTURING RECORD, THERE ARE NO INCIDENCES REPORTED REGARDING THIS ISSUE AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: WE CONCLUDE THAT THIS COMPLAINT IS CONFIRMED. 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: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE. MOREOVER, TRAINING REGARDING THIS ISSUE TO PRODUCTION PERSONNEL WAS DONE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CLIENT REPORTED THAT THE NEEDLE LOOSENED FROM THE THREAD AND THAT IT HAPPENED ON 3 OCCASIONS. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505451 NOVOSYN UNDYED 2/0 (3) 70CM DS24 (M)RCP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C0069236N1 3145E8

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown