BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 1 (4) 90CM HS37S (M)

    MDR report key: 15127714 · Received July 29, 2022

    Report

    Report Number
    3003639970-2022-00339
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    July 8, 2022
    Report Date
    July 29, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 576 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED AN OPEN BOX LABELLED AS MONOSYN VIOLET 1 (4) 90CM HS37S (M) DDP; CODE C0022478 AND BATCH 122073, WHICH CONTAINS 9 UNOPENED POUCHES INSIDE. 7 OF THEM OF THE SAME CODE-BATCH AS THE PRODUCT BOX LABEL BUT 2 POUCHES OF ANOTHER CODE-BATCH (CODE 0023620 - MONOSYN UNDYED 2/0 (3) 70CM FR26 DDP AND BATCH 122073). THIS PROBLEM OCCURRED IN THE MANUFACTURING PROCESS, THE "CLEAN LINE" OPERATION WAS NOT PERFORMED CORRECTLY, AND THE OPERATOR PACKED 2 UNITS OF MONOSYN UNDYED 2/0 CODE-BATCH 0023620-122073 INSIDE THE PRODUCT BOX OF THE MONOSYN VIOLET 1 CODE-BATCH C0022478- 122073 BY MISTAKE. AS NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS ISSUE FOR THIS REFERENCE-BATCH, IT HAS BEEN DETERMINED THAT THE MIX-UP WAS THE ONE INFORMED BY THE CUSTOMER, ASSUMING AN ISOLATED BOX. REMARKS: WE HAVE INFORMED THE PERSONNEL INVOLVED OF THIS ISSUE. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE SAMPLES RECEIVED. WE APOLOGISE FOR ANY INCONVENIENCE THAT 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 MONOSYN SUTURE. THE CLIENT (VETERINARY) REPORTED THAT INSIDE THE REFERENCE BOX C0022478 THE CLIENT HAS FOUND 2 UNITS OF ANOTHER REFERENCE OF MONOSYN. FURTHER INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317109 MONOSYN VIOLET 1 (4) 90CM HS37S (M) SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C0022478 122073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown