BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2/0 (3) 90CM HR26 (M) RCP

    MDR report key: 13648012 · Received March 2, 2022

    Report

    Report Number
    3003639970-2022-00067
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 2, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. UNDER PMA/510(K) NUMBER: K122734. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED A BOX FROM THE CUSTOMER FOR ANALYSIS. THE BOX LABEL AND PRODUCT INSIDE IS OF NOVOSYN CODE C0068542N1 (NOVOSYN VIOLET 2/0 (3) 90CM HR26 (M) RCP) AND BATCH 3121V6, BUT THE BOX THAT CONTAINS THE PRODUCT IS A SAFIL PRE-PRINTED BOX INSTEAD OF NOVOSYN PRE-PRINTED BOX. THIS MISTAKE TOOK PLACE AT THE MOMENT OF SELECTION OF PRE-PRINTED BOX OF THE PRODUCT IN THE WAREHOUSE. THREE BOXES OF THIS CODE-BATCH WERE RECONDITIONED IN WAREHOUSE AND THE OPERATOR TOOK BY MISTAKE A SAFIL BOX INSTEAD OF A NOVOSYN'S. AT THE TIME THE COMPLAINT WAS RECEIVED, THERE WERE TWO BOXES IN THE WAREHOUSE THAT WERE CHECKED, AND THE SAME DEFECT WAS FOUND. THESE TWO BOXES WERE RECONDITIONED AGAIN BEFORE BEING DISTRIBUTED, SO THERE ARE NO MORE AFFECTED BOXES IN THE MARKET FROM THIS CODE-BATCH WITH THIS PROBLEM. 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. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PRODUCT BOX RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE BOX 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, WE OPENED AN INC IN THE SYSTEM TO CORRECT/PREVENT THIS DEFECT TO HAPPEN.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CLIENT REPORTED THAT THE PACKAGING OF THE PRODUCT IS WRONG, THERE IS A MISS MATCH AMONG THE LABELLING WHICH CORRESPONDS TO NOVOSYN AND THE PRE-PRINTED BOX THAT CORRESPONDS TO SAFIL. PROBABLY INSIDE THE BOX (UNOPENED) THE PRODUCT IS NOVOSYN. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873885 NOVOSYN VIOLET 2/0 (3) 90CM HR26 (M) RCP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C0068542N1 3121V6

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown