BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 5/0 (1) 45CM DGMP13

    MDR report key: 12560894 · Received October 1, 2021

    Report

    Report Number
    3003639970-2021-00483
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Report Date
    October 1, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS AND RESULTS: THERE ARE PREVIOUS COMPLAINTS OF THIS CODE-BATCH REGARDING THE SAME ISSUE AND CLOSED AS CONFIRMED AFTER ANALYSIS. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 20 CLOSED SAMPLES TO ANALYZE THIS COMPLAINT. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF ALL CLOSED SAMPLES RECEIVED AND THE RESULTS DO NOT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP), WE HAVE FOUND 7 OF THE 20 SAMPLES TESTED WITH THE NEEDLE DETACHED FROM THE THREAD WHEN OPENING THE PACKS. THE NEEDLE ATTACHMENT STRENGTH RESULTS ARE: 0.48 KGF IN AVERAGE AND 0.03 KGF IN MINIMUM (EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS AND THAT THERE ARE PREVIOUS CONFIRMED COMPLAINTS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. ACTIONS ON DISTRIBUTED PRODUCT 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 · 1

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT THE THREAD DETACHES FROM THE NEEDLE. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457868 MONOSYN UNDYED 5/0 (1) 45CM DGMP13 SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C0023706 120514

    Patients

    Seq Age Sex Outcome Treatment
    1