BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECUREX P 3/0 (2) 45CM DS24 (M)

    MDR report key: 11454157 · Received March 10, 2021

    Report

    Report Number
    3003639970-2021-00048
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Report Date
    May 21, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A PICTURE WHERE WE CAN SEE A PIECE OF SUTURE (NEEDLE ATTACHED TO THE THREAD) AND THE YELLOW CLIP OF THE SECUREX SUTURE, IN THE OTHER IT CAN BE SEEN THE RED CLIP OF THE SECUREX IN THE PATIENT. HOWEVER, WITHOUT CLOSED AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT 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.

    Additional Manufacturer Narrative · 1

    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. PMA/510(K): K980703. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH SECUREX SUTURE. THE CLIENT REPORTED THAT IN THE PROCESS OF STITCHING, IT WAS FOUND THAT THE SUTURE WAS BROKEN. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349732 SECUREX P 3/0 (2) 45CM DS24 (M) OTHER SUTURE GAW B. BRAUN SURGICAL, S.A. G0994326 119091

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR