BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP

    MDR report key: 6650104 · Received June 19, 2017

    Report

    Report Number
    3003639970-2017-00325
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 22, 2017
    Report Date
    July 6, 2017
    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

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS WITHDRAWING THE NEEDLE THE THREAD WOULD GET STUCK AND THEN EVENTUALLY BREAK. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2017-00306, 3003639970-2017-00325, 3003639970-2017-00326, 3003639970-2017-00327.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN RACEPACK. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME BATCH. WE MANUFACTURED (B)(4) OF THIS BATCH. THERE ARE 12 UNITS IN OUR STOCK THAT HAVE BEEN REQUESTED FOR ANALYSIS. WE HAVE RECEIVED ONE OPEN SAMPLE (MANIPULATED BUT UNUSED) FROM THE CUSTOMER. THE THREAD IS TANGLED INSIDE THE RACEPACK AND THERE IS A PIECE OF THREAD OUT OF THE CHANNEL OF THE PLASTIC CARRIER. THE FACT THAT THE THREAD BECOMES TANGLED COULD CAUSE DAMAGE THREAD SURFACE OR THREAD BREAKAGE WHEN PULLING OUT THE SUTURE FROM THE PACK. OUR ENGINEERING DEPARTMENT IS INFORMED ABOUT THIS ISSUE AND IS TESTING AND ANALYZING OTHER PRODUCT PACKAGING DESIGNS IN ORDER TO AVOID THESE KIND OF INCIDENCES. REMARKS: THE SUTURE SHOULD BE PULLED OUT FROM THE PACKAGING RIGHTWARDS, AVOIDING THE SUTURE EXTRACTION FROM THE UPPER SIDE. IF THE SUTURE IS PULLED OUT FROM THE PACKAGING BY THE UPPER PART, THE THREAD COULD BE TANGLED. PLEASE NOTE THAT TWO MOVEMENTS NEED TO BE DONE TO PULL OUT THE SUTURE FROM THE PACKAGING ACCORDING TO THE DESIGN OF DOUBLE ARMED SUTURES PACKED IN RACEPACK: - FIRST ONE FOR PULLING OUT THE FIRST NEEDLE AND THREAD. - SECOND ONE TO PULL OUT THE SECOND NEEDLE. THIS PRODUCT HAS BEEN MANUFACTURED WITH THE CURRENT DESIGN OF WINDING AND PACKAGING. ON THE OTHER HAND, WE HAVE ALSO TESTED 12 UNITS FROM STOCK. PULL OUT OF SUTURE IN THE SAMPLES AVAILABLE IN OUR STOCK IS CORRECT AND THE CURRENT ONE. SUTURE HAS BEEN PULLED OUT WITHOUT DIFFICULTY AND DOES NOT BECOME TANGLED. NO DAMAGE ON THREAD SURFACE HAS BEEN FOUND EITHER. WE HAVE ALSO TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES FROM THE STOCK AND THE RESULTS FULFIL REQUIREMENTS: A 1.84 KGF IN AVERAGE AND 1.41 KGF IN MINIMUM (REQUIREMENTS: 0.92 KGF IN AVERAGE AND 0.31 KGF IN MINIMUM). CORRECTIVE/PREVENTIVE ACTIONS: THERE IS AN IMPROVEMENT PROJECT IN ORDER TO AVOID THESE KIND OF INCIDENTS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430176 OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP SUTURES GAW B.BRAUN SURGICAL SA C3090908 116423V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other