BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 1 (4) 70CM HR26 (M)

    MDR report key: 8993574 · Received September 11, 2019

    Report

    Report Number
    3003639970-2019-00648
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    July 26, 2019
    Report Date
    September 16, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: ONE OPEN POUCH (FIRST POUCH OPENED, ALUMINUM POUCH CLOSED). ANALYSIS AND RESULTS: THIS IS THE SECOND COMPLAINT OF THIS CODE BATCH FOR THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE SAMPLE WITH OUTER POUCH OPEN (FIRST PACK IS CLOSED). THE OPEN SAMPLE RECEIVED HAS THE FIRST PACK SEALED TO SECOND PACK (THE ALUMINUM POUCH IS STUCK TO THE PLASTIC FILM) IN THE FOURTH SEALING. THIS DEFECT IS DUE TO AN ACCIDENTAL EFFECT OF THE WELDING MACHINE AND THE PERSONNEL INVOLVED IN THIS PROCESS DID NOT SORT OUT THIS UNIT. CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLE RECEIVED. ACTIONS ON PRODUCT: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    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. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER PACKAGE COULD NOT BE REMOVED FROM THE OUTER PACKAGE. THE REPORTER INDICATED THAT INNER FOIL IS "WELDED" WITH THE OUTER FOIL. THE EVENT OCCURRED PRE-OPERATIVELY WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792119 NOVOSYN VIOLET 1 (4) 70CM HR26 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0068044 119053V031

    Patients

    Seq Age Sex Outcome Treatment
    1