BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 2/0 (3) 150CM HR26 (M)

    MDR report key: 6949712 · Received October 13, 2017

    Report

    Report Number
    3003639970-2017-00518
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 20, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    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: GERMANY IT WAS REPORTED THAT THE THREAD BROKE DURING USE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN UNIT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND USED SAMPLE WITH THE THREAD BROKEN. HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. 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. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 4.11 KGF IN AVERAGE AND 3.94 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 2.73 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM). LINEAR PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 6.39 KGF IN AVERAGE AND 5.48 KGF IN MINIMUM AND FULFILLED THE REQUIREMENT OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENT: 4.69 KGF IN AVERAGE). 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. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727076 MONOMAX VIOLET 2/0 (3) 150CM HR26 (M) SUTURES NWJ B.BRAUN SURGICAL SA B0041444 114274V026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other