BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 4/0(1.5)4X45CM HR22TOM

    MDR report key: 8833762 · Received July 26, 2019

    Report

    Report Number
    3003639970-2019-00562
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Report Date
    July 26, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. K122734. SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS, PICTURE ATTACHED. 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 NOT RECEIVED ANY SAMPLE FROM THE CUSTOMER. NEVERTHELESS, WE HAVE RECEIVED A PICTURE THAT SHOWS ONE OPEN AND UNUSED SAMPLE THAT CONTAINS FIVE SUTURES INSIDE THE PACK INSTEAD OF FOUR AS INDICATED IN THE PRODUCT DESCRIPTION, CAUSED BY A HUMAN MISTAKE DURING PRODUCTION PROCESS. INVOLVED PERSONNEL WILL BE INFORMED ABOUT THIS INCIDENCE. 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 PICTURE RECEIVED SHOWS A SAMPLES THAT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE PICTURE RECEIVED. 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS COMPENSATION. A CAPA HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE IS AN EXTRA NEEDLE IN SUTURE. THE REPORTER INDICATED THAT THE SURGEON FOUND THAT THERE WAS AN EXTRA NEEDLE SUTURE IN THE PACKAGE. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623471 NOVOSYN VIOLET 4/0(1.5)4X45CM HR22TOM SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0088729 718403

    Patients

    Seq Age Sex Outcome Treatment
    1