BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 1 (4) 70CM HR22S (M)

    MDR report key: 9539028 · Received January 2, 2020

    Report

    Report Number
    3003639970-2019-00950
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Report Date
    January 2, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4). THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN AND EMPTY PACK. THE SUPPORT CARDBOARD HAS BEEN VISUALLY ANALYZED AND WE CAN SEE THAT THERE ARE NO MARKS OF THE NEEDLE IN IT. IN CONSEQUENCE, A SUTURE WAS NEVER PLACED IN IT. AS NO OTHER COMPLAINTS HAVE BEEN RECEIVED WE CONSIDER THAT THIS IS AN ISOLATED AND ACCIDENTAL UNIT NOT CORRECTLY DISCARDED BY THE WINDING MACHINE. 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 RESULTS OF SAMPLE RECEIVED DOES NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLE 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACK IS EMPTY. THE REPORTER INDICATED THAT THERE IS NO PRODUCT IN THE PACKAGING. THE EVENT OCCURRED DURING A SURGICAL PROCEDURE WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061 NOVOSYN VIOLET 1 (4) 70CM HR22S (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0068038 119262

    Patients

    Seq Age Sex Outcome Treatment
    1