BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 7/0 (0,5) 4X60CM 2XDR10CV2LP

    MDR report key: 16352086 · Received February 10, 2023

    Report

    Report Number
    3003639970-2023-00025
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    November 23, 2022
    Report Date
    February 10, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K: REPORTED DEVICE MARKETED IN THE U.S., ONLY FOR VETERINARY USE, 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: K133890. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED (B)(4) UNITS. THERE ARE 144 UNITS BLOCKED IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 11 CLOSED SAMPLES TO ANALYZE THIS CASE. WE HAVE CHECKED THE SAMPLES RECEIVED AND THEY CONTAIN ONLY 2 SUTURES INSTEAD OF 4 SUTURES. THIS DEFECT IS CAUSED BY A HUMAN MISTAKE DURING PRODUCTION PROCESS. THE PRODUCT SHOULD HAVE 4 SUTURES INSIDE. 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: TAKING INTO ACCOUNT THAT THE SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE SAMPLES RECEIVED. ACTIONS ON DISTRIBUTED PRODUCT 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 OPTILENE SUTURE. THE CLIENT REPORTED THAT THERE WERE A WRONG NUMBERS OF SUTURES INSIDE THE STERILE PACKAGING, BEING 2 SUTURES INSTEAD OF 4 SUTURES. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067293 OPTILENE 7/0 (0,5) 4X60CM 2XDR10CV2LP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. G3097371 121145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown