BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M)

    MDR report key: 11567220 · Received March 25, 2021

    Report

    Report Number
    3003639970-2021-00089
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Report Date
    April 8, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED 18,108 UNITS OF THIS CODE-BATCH. THERE ARE 108 UNITS IN OUR STOCK (BLOCKED). WE HAVE RECEIVED SOME PICTURES SHOWING A PRODUCT BOX LABELED AS NOVOSYN VIOLET 3/0 (2) 70CM HR26, CODE C0068041 AND BATCH 120402, BUT IT CONTAINS THE PRODUCT NOVOSYN VIOLET 2/0 (3) HR30, CODE 0068047 AND BATCH 120402. BOTH PRODUCTS WERE PACKED ONE AFTER THE OTHER THE SAME DAY IN MANUFACTURING LINE. WE ASSUME THAT THE OPERATION OF CLEAN LINE WAS NO PERFORMED CORRECTLY AND ONE BOX THAT CONTAINS NOVOSYN REF. 0068047 WAS LABELLED AS NOVOSYN REF. 0068041. ON THE OTHER HAND, WE HAVE CHECKED ONE BOX AVAILABLE IN STOCK AND IS CORRECT, THE PRODUCT INSIDE THE BOX MATCHES WITH BOX LABELING (NOVOSYN VIOLET 3/0 70CM HR26, REF. C0068041 AND BATCH 120402). AS NO OTHER COMPLAINTS FOR THIS CODE-BATCH HAVE BEEN RECEIVED AND THE BOX REVIEWED FROM STOCK IS CORRECT, WE CONSIDER THAT THIS IS AN ISOLATED AND ACCIDENTAL BOX. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PICTURES RECEIVED SHOW A PRODUCT BOX THAT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE PICTURES RECEIVED. 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS COMPENSATION. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CLIENT REPORTED THAT THE OUTER LABEL OF THE PACKAGE READS (B)(4), 3/0 BUT INSIDE THE PACKAGE THERE ARE (B)(4), 2/0 THREADS. THE PICTURES PROVIDED BY THE CUSTOMER SHOW A POUCH OF ANOTHER NOVOSYN REFERENCE (MODEL NUMBER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467917 NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C0068041 120402

    Patients

    Seq Age Sex Outcome Treatment
    1