BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 4/0 (1,5) 45CM DS19 (M) RCP

    MDR report key: 8370557 · Received February 26, 2019

    Report

    Report Number
    3003639970-2019-00227
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Report Date
    August 1, 2019
    Manufacturer
    B/ BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K133890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION - ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. THERE ARE 12 UNITS IN OUR STOCK THAT HAVE BEEN BLOCKED. WE HAVE RECEIVED 55 UNOPENED RACEPACKS TO ANALYZE THIS COMPLAINT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). WE HAVE ALSO TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). NEVERTHELESS, WE HAVE FOUND SPLITTING ON THREAD SURFACE IN SOME OF THE CLOSED SAMPLES RECEIVED AFTER PERFORMING NEEDLE ATTACHMENT STRENGTH TEST (SEE ENCLOSED PICTURE). PROBABLY, IT IS CAUSED DUE TO AN EXCESSIVE STRENGTH APPLIED TO ATTACH THE THREAD TO THE NEEDLE. 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. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN OPTILENE SUTURE PACK. THE SUTURE WAS SPLITTING; IT WAS CLARIFIED THAT IT DID NOT BREAK BUT "PULLED FIBER". ADDITIONAL INFORMATION SUCH AS PATIENT DATA IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164893 OPTILENE 4/0 (1,5) 45CM DS19 (M) RCP OTHER SUTURE GAW B/ BRAUN SURGICAL SA C3090220 118462

    Patients

    Seq Age Sex Outcome Treatment
    1