BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP

    MDR report key: 14286432 · Received May 5, 2022

    Report

    Report Number
    3003639970-2022-00198
    Event Type
    Injury
    Date Received
    May 5, 2022
    Report Date
    May 19, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICE 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.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH REGARDING THE SAME ISSUE AND FROM THE SAME END CUSTOMER, CLOSED AS NOT CONFIRMED AFTER THE ANALYSIS. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE- BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 67 CLOSED SAMPLES TO ANALYZE THIS CASE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.41 KGF IN AVERAGE AND 0.38 KGF IN MINIMUM (EP REQUIREMENTS: 0.15 KGF IN AVERAGE AND 0.06 KGF IN MINIMUM). ALSO, WE HAVE TESTED THE LINEAR PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS ARE: 0.54 KGF IN AVERAGE AND 0.53 KGF IN MINIMUM, AND THESE RESULTS ARE CORRECT AND USUAL VALUES FOR THIS THREAD AND SIZE. THERE ARE NO EUROPEAN PHARMACOPOEIA AND UNITED STATES PHARMACOPEIA LIMITS FOR THIS TEST. SEWING TEST ON ARTIFICIAL SKIN TISSUE HAS BEEN CONDUCTED WITH THE CLOSED SAMPLES RECEIVED AND FRAYING/SPLITTING DOES NOT APPEAR WHEN PULLING THE THREAD THROUGH THE TISSUE. VISUAL APPEARANCE OF THE SAMPLES TESTED BEFORE AND AFTER PERFORMING THIS TEST IS THE USUAL ONE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. WE HAVE ALSO REVIEWED THE COMPLAINT HISTORY RECORD, AND THERE ARE NO PREVIOUS COMPLAINTS IN ANY OF THE OTHER PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCHES USED IN THIS PRODUCT (ONLY THE COMPLAINT OF THE SAME CODE-BATCH REGARDING THE SAME ISSUE MENTIONED PREVIOUSLY). REMARKS: WHEN WORKING WITH OPTILENE® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN TO AVOID ANY CRUSHING OR CRIMPING DAMAGE OF THE MONOFILAMENT BY INSTRUMENTS SUCH AS FORCEPS OR NEEDLE HOLDERS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT A PATIENT WAS RE-INTERVENED DUE TO BLEEDING A FEW DAYS AFTER SURGERY. DURING THE REOPERATION, IT WAS OBSERVED THAT THE SUTURE WAS BROKEN. THE KNOT WAS CORRECT, IT WAS NOT UNDONE. THE SUTURED MATERIAL WAS A PERICARDIAL PATCH OVER AN ENDARTERECTOMISED COMMON FEMORAL ARTERY. THE PATIENT REQUIRED PROLONGED PROPHYLACTIC ANTIBIOTIC TREATMENT. HE RECOVERED WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    INITIAL CASE DESCRIPTION: IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT A PATIENT WAS RE-INTERVENED DUE TO BLEEDING A FEW DAYS AFTER SURGERY. DURING THE REOPERATION, IT WAS OBSERVED THAT THE SUTURE WAS BROKEN. THE KNOT WAS CORRECT, IT WAS NOT UNDONE. THE SUTURED MATERIAL WAS A PERICARDIAL PATCH OVER AN ENDARTERECTOMISED COMMON FEMORAL ARTERY. THE PATIENT REQUIRED PROLONGED PROPHYLACTIC ANTIBIOTIC TREATMENT. HE RECOVERED WELL. ADDITIONAL INFORMATION RECEIVED: THE INITIAL SURGERY WAS OF NORMAL DURATION. THE SURGERY TO REPAIR THE COMPLICATION WAS LABORIOUS AND URGENT, THE DURATION OF SURGERY CAN BE CONSIDERED NORMAL ACCORDING TO THE COMPLICATION THAT AROSE. THIS INCIDENT OCCURRED LESS THAN 10 DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839714 OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097906 121475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown