BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV2 RCP

    MDR report key: 18835457 · Received March 5, 2024

    Report

    Report Number
    3003639970-2024-00094
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 15, 2024
    Report Date
    March 27, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 1 CLOSED SAMPLE FOR ANALYSIS. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLE RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.29 KGF IN AVERAGE AND 0.27 KGF IN MINIMUM (EP REQUIREMENTS: 0.17 KGF IN AVERAGE AND 0.082 KGF IN MINIMUM). BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE CLOSED SAMPLE RECEIVED COMPLIES WITH USP/EP AND B. BRAUN SURGICAL REQUIREMENTS FOR NEEDLE ATTACHMENT STRENGTH. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLE RECEIVED FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLE RECEIVED. CORRECTIVE MEASURES: 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 · 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., K133890. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT DURING HEART VALVE REPAIR SURGERY, THE SUTURE THREAD (OPTILENE 6/0 2XDRC10) BREAKS AT THE NEEDLE JUNCTION, LEAVING THE NEEDLE AND SUTURE THREAD SEPARATED AND UNUSABLE. THE CUSTOMER REFUSED TO PROVIDE PATIENT DATA BECAUSE THE PATIENT WAS NOT HARMED AND AN ALTERNATIVE BRAND WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137913 OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. G3097546 123173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose