BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP

    MDR report key: 8811884 · Received July 22, 2019

    Report

    Report Number
    3003639970-2019-00547
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Report Date
    August 1, 2019
    Manufacturer
    B/ BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION - ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. THERE ARE 864 UNITS IN OUR STOCK. WE HAVE RECEIVED THREE CLOSED SAMPLES TO ANALYZE THE THREE CASES.(REPORTED SEPARATELY). WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE 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/BREAKAGE IN THE THREAD. THE NEEDLE ATTACHMENT STRENGTH RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). WE HAVE NOT FOUND SPLITTING ON THREAD SURFACE ON THE CLOSED SAMPLES RECEIVED BEFORE AND AFTER PERFORMING TESTS. 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. FURTHERMORE, WE HAVE CONDUCTED A REVIEW OF THE COMPLAINT HISTORY RECORD AND THERE ARE NO OTHER COMPLAINTS RECEIVED REGARDING THREAD BREAKAGE OF THE SEVERAL PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCH AS THE COMPLAINED PRODUCT. AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) OF THE PRODUCT, 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. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 1

    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. K0133890. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SUTURES BROKE AT THE KNOT. THE REPORTER (DENTIST) INDICATED THAT THE SUTURE BROKE AT THE KNOT A FEW DAYS AFTER SURGERY. THIS EVENT OCCURRED WITH THREE DENTAL PATIENTS. ADDITIONAL INFORMATION IS NOT AVAILABLE. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607929 OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP OTHER SUTURE GAW B/ BRAUN SURGICAL SA C3090211 119034

    Patients

    Seq Age Sex Outcome Treatment
    1