BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILENE 5/0 (1) 75CM 2XDRC13 CV RCP

    MDR report key: 8584421 · Received May 6, 2019

    Report

    Report Number
    3003639970-2019-00320
    Event Type
    Injury
    Date Received
    May 6, 2019
    Report Date
    May 6, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. 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. K133890. INVESTIGATION: SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS FOR THE POSSIBLE BATCHES 118371, 118271, 118262 AND 117174. THERE ARE TWO PREVIOUS COMPLAINTS FOR THE BATCH 118202 REGARDING OTHER ISSUE (NEEDLE DETACHMENT). WE MANUFACTURED (B)(4) UNITS OF THE BATCH 117174, (B)(4) UNITS OF THE BATCH 118202, (B)(4) UNITS OF THE BATCH 118262, (B)(4) UNITS OF THE BATCH 118271, (B)(4) UNITS OF THE BATCH 118371. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE IN B. BRAUN SURGICAL, (B)(4), WE HAVE ONLY BEEN ABLE TO REVIEW THE BATCH MANUFACTURING RECORDS OF THE POSSIBLE INVOLVED PRODUCTS. THERE ARE NO INCIDENCES RELATED TO THIS INCIDENCE AND THE RESULTS DURING THE PROCESS FULFIL 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. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE OR MORE INFORMATION IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED.

    Description of Event or Problem · 0

    IT WAS REPORTED SUTURE TORE THE VEIN INTRA-OPERATIVELY. THE REPORTER INDICATED THE SURGEON TORE THE VEIN WITH THE THREAD BETWEEN THE POINT OF INSERTION AND THE POINT OF EJECTION OF A VEIN. THE REPORTER STATED THE SURGEON'S ASSUMPTION IS THAT THE PUNCTURE CHANNELS ARE TOO LARGE AND THAT THE TEARING OCCURRED AS A RESULT. THE SURGEON WAS ABLE TO STOP THE BLEEDING THAT OCCURRED. IT WAS ALSO REPORTED THE NEEDLE WOULD BECOME BLUNT AFTER APPROXIMATELY 10 PUNCTURES, WHEREAS, THE SURGEON STATED A COMPETITOR'S PRODUCT WOULD LAST A MUCH LONGER DISTANCE. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375453 OPTILENE 5/0 (1) 75CM 2XDRC13 CV RCP CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C3095141

    Patients

    Seq Age Sex Outcome Treatment
    1 Other