BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8597198 · Received May 9, 2019

    Report

    Report Number
    3003639970-2019-00398
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 9, 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, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K133890. SAMPLES RECEIVED: 15 UNOPENED RACE PACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. (B)(4). WE HAVE RECEIVED 15 CLOSED SAMPLES FOR ANALYSIS. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.45 KGF IN AVERAGE AND 0.41 KGF IN MINIMUM (EP REQUIREMENTS: 0.15 KGF IN AVERAGE AND 0.06 KGF IN MINIMUM). 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. 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 BREAKS VERY EASY DURING KNOTTING. IT WAS REPORTED DURING ANASTOMOSIS OF THE FEMORAL ARTERY THE THREAD BREAKS VERY EASY DURING KNOTTING. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO OTHER PATIENT DATA OR INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391289 OPTILENE 6/0 (0,7) 75CM 2XDRC10 CV RCP CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C3090546 118251V004

    Patients

    Seq Age Sex Outcome Treatment
    1