BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 4/0 (1,5) 90CM 2XHR22 CV RCP

    MDR report key: 8552561 · Received April 25, 2019

    Report

    Report Number
    3003639970-2019-00374
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    April 25, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K133890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 OPEN RACEPACK AND TWO CLOSED RACEPACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED TWO CLOSED SAMPLES AND ONE OPEN SAMPLE WITH SPLITTING/FRAYING IN THE THREAD SURFACE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). ADDITIONALLY, NEEDLE ATTACHMENT STRENGTH TEST HAS BEEN CONDUCTED ON THE CLOSED SAMPLES RECEIVED IN ORDER TO DISCARD A FAULTY NEEDLE ATTACHMENT DURING MANUFACTURING PROCESS THAT COULD CAUSE SPLITTING/FRAYING IN THE THREAD. THE NEEDLE ATTACHMENT STRENGTH RESULTS FULFIL THE REQUIREMENTS OF THE EP. WE HAVE NOT FOUND SPLITTING ON THREAD SURFACE ON THE CLOSED SAMPLES RECEIVED BEFORE AND AFTER PERFORMING TESTS. REVIEW OF THE BATCH MANUFACTURING RECORD SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EP/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH OPTILENE. DURING A PROCEDURE AT THE CARDIAC SURGERY CENTER, WHEN THE SUTURE PACK WAS OPENED IT WAS NOTED TO BE DEFECTIVE. THE SUTURE WAS SPLITTING AND HAD A DAMAGED SURFACE. A SECOND PACK WAS OPENED BUT HAD THE SAME MALFUNCTION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341557 OPTILENE 4/0 (1,5) 90CM 2XHR22 CV RCP CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C3090976 116446

    Patients

    Seq Age Sex Outcome Treatment
    1