BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 2/0 (3) 90CM HR30 (M)

    MDR report key: 14773121 · Received June 22, 2022

    Report

    Report Number
    3003639970-2022-00292
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Report Date
    July 27, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 21 CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF ALL SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 1.63 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM (EP REQUIREMENTS: 1.12 KGF IN AVERAGE AND 0.46 KGF IN MINIMUM) REVIEWED THE BATCH MANUFACTURING RECORD, THERE ARE NO INCIDENCES REPORTED REGARDING THIS ISSUE AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOMAX SUTURE. THE CLIENT REPORTED THAT THE NEEDLE COMES OFF THE THREAD. NO PATIENT INVOLVEMENT, OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599191 MONOMAX VIOLET 2/0 (3) 90CM HR30 (M) SYNTHETIC ABSORBABLE MONOFILAR SUTURE NWJ B. BRAUN SURGICAL, S.A. B0041278 121461

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown