BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8603725 · Received May 13, 2019

    Report

    Report Number
    3003639970-2019-00400
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 13, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    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, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K133890 SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND MOSTLY DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE 8 UNITS IN OUR STOCK THAT HAVE BEEN REQUESTED FOR ANALYSIS. WE HAVE NOT RECEIVED ANY SAMPLE FROM THE CUSTOMER FOR ANALYSIS. HOWEVER, WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED FROM STOCK AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):0.42 KGF IN AVERAGE AND 0.39 KGF IN MINIMUM (EP REQUIREMENTS: 0.15 KGF IN AVERAGE AND 0.06 KGF IN MINIMUM). A REVIEWED OF THE BATCH MANUFACTURING RECORD FOR THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THREAD BROKE VERY EASY. THE REPORTER INDICATED THAT DURING A PATCH SUTURE IN A CONGENITAL DUODENAL OBSTRUCTION (CDO) PROCEDURE THE SUTURE THREAD BREAKS VERY EASY. THERE WAS NO PATIENT HARM AND EVERYTHING WAS GOOD. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397064 OPTILENE 6/0 (0,7) 75CM 2XDR13 CV RCP CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C3095906 118416V013

    Patients

    Seq Age Sex Outcome Treatment
    1