BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 2/0 (3) 70CM FR26 (M)

    MDR report key: 8070889 · Received November 14, 2018

    Report

    Report Number
    3003639970-2018-00716
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 14, 2018
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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: THERE ARE NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS - THERE ARE NO PREVIOUS COMPLAINTS NOR UNITS IN OUR STOCK FOR THE THREE POSSIBLE BATCHES (118142, 118143, AND 118173). WITHOUT A SAMPLE, WE CANNOT CARRY OUT A COMPLETE ANALYSIS. NEVERTHELESS, WE HAVE TESTED THE BENDING STRENGTH OF NEEDLES AVAILABLE IN STOCK OF THE SAME NEEDLE RAW MATERIAL BATCHES, AND THE RESULTS FULFILL THE SPECIFICATION FOR THESE NEEDLES. IN REVIEWING THE BATCH MANUFACTURING RECORDS OF THESE PRODUCTS, THERE WERE NO INCIDENTS RELATED TO THESE ISSUES AND THE RESULTS DURING THE PROCESS FULFILLED REQUIREMENTS. REMARKS: WHEN WORKING WITH MONOMAX 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. CARE SHOULD BE TAKEN TO AVOID DAMAGING THE NEEDLE WHEN USING THE SUTURE MATERIAL. ALWAYS GRASP THE NEEDLE IN A SECTION 1/3 TO 1/2 OF THE DISTANCE FROM THE FIBER ATTACHMENT END TO THE NEEDLE POINT, AND NEVER AT THE END WHERE THE FIBER IS ATTACHED OR THE NEEDLE POINT. GRASPING THE NEEDLE AT THE AREA OF ITS POINT COULD IMPAIR THE PENETRATION PERFORMANCE AND CAUSE A FRACTURE OF THE NEEDLE. GRASPING THE NEEDLE CLOSE TO THE FIBER ATTACHMENT END COULD CAUSE BENDING OR BREAKAGE. RESHAPING NEEDLES SHOULD BE AVOIDED AND MAY RESULT IN A LOSS OF THEIR STRENGTH AND RESISTANCE TOWARDS BENDING AND BREAKING. FINAL CONCLUSION - NO SAMPLES WERE PROVIDED AND TESTING COULD NOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, THE CASE WILL BE RE-OPENED AND THE PRODUCT FURTHER ANALYZED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL TIMES THE SUTURES HAVE BROKEN DURING AN OPERATION CAUSING LONGER OPERATION TIME. IT WAS NOTED THAT ONE CASE INVOLVED A C-SECTION. SOMETIMES NEEDLES ARE BROKEN AND SOMETIMES THE INNER PACKAGE HAS STUCK TO THE OUTER PACKAGE. THIS REPORT ADDRESSES THE SUTURES THAT HAD BROKEN. ADDITIONAL INFORMATION WAS NOT PROVIDED. ALL MEDWATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2018-00735; 3003639970-2018-00736.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908466 MONOMAX VIOLET 2/0 (3) 70CM FR26 (M) SYNTHETIC ABSORBABLE MONOFILAR NWJ B. BRAUN SURGICAL SA B0041887

    Patients

    Seq Age Sex Outcome Treatment
    1