BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1 (4) 70CM JRC30S (M)

    MDR report key: 14101554 · Received April 13, 2022

    Report

    Report Number
    3003639970-2022-00170
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Report Date
    September 12, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 THREE PREVIOUS COMPLAINTS OF THIS CODE-BATCH REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS BUT SOME PICTURES SHOWING OPEN SAMPLES WITH THE THREADS MELTED. HOWEVER, TAKING INTO ACCOUNT THE PICTURES RECEIVED AND THAT THERE ARE PREVIOUS CONFIRMED COMPLAINTS FOR THE SAME ISSUE, WE CONSIDER THIS CASE AS CONFIRMED. 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. THE DAMAGED UNITS HAVE BEEN PROBABLY SUBMITTED TO HIGH TEMPERATURE AND THREADS HAVE MELTED. AFTER AN INTERNAL INVESTIGATION, IT HAS BEEN DETERMINED THAT THE ROOT CAUSE OF THIS DEFECT IS LOCATED IN THE PACKAGING STEP OF MANUFACTURING PROCESS. CONSIDERING THAT IT HAS BEEN POSSIBLE TO REPRODUCE THE SAME ISSUE INTERNALLY ONLY IN SOME THREADS, WE CONSIDER THAT THESE ARE ISOLATED UNITS. THE PERSONNEL INVOLVED HAS BEEN INFORMED TO AVOID THAT THIS ISSUE HAPPENS AGAIN. FINAL CONCLUSION: TAKING INTO ACCOUNT THE PICTURES RECEIVED SHOW SAMPLES THAT DO NOT FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS AND THAT THERE ARE PREVIOUS CONFIRMED COMPLAINTS FOR THE SAME ISSUE, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. 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 WHEN HE OPENED THE PACKAGE DURING SURGERY, THE SUTURE WAS MELTED AND ALSO THE NEEDLE HAD DETACHED FROM THE THREAD. WHEN THE SURGEON OPENED ANOTHER PACKAGE, IT WAS ALSO MELTED AND WHEN HE TRIED TO USE THE SUTURE, THE NEEDLE CAME OFF THE THREAD AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669239 MONOMAX VIOLET 1 (4) 70CM JRC30S (M) SYNTHETIC ABSORBABLE MONOFILAR SUTURE NWJ B. BRAUN SURGICAL, S.A. B0041560 121165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown