BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL C VIOLET 2 (5) 15M

    MDR report key: 9820970 · Received March 11, 2020

    Report

    Report Number
    3003639970-2020-00136
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Report Date
    March 10, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    K031286. 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. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 17 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. 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. WE HAVE RECEIVED ONE OPEN AND USED CASSETTE WITHOUT THE DATE OF CASSETTE'S OPENING WRITTEN. THREAD IN THE CASSETTE RECEIVED BREAKS EASILY, THE THREAD IS DEGRADED. THREAD DEGRADES BY HYDROLYSIS BECAUSE OF AIR HUMIDITY, THEREFORE IT MUST BE USED WITHIN 6 MONTHS ONCE OPENED AS INDICATED ON CASSETTE LABEL: ONCE OPENED, THE CONTENT OF THE CASSETTE SHOULD BE USED WITHIN 6 MONTHS AND PRIOR TO EXPIRATION DATE. AS THE DATE OF CASSETTE'S OPENING IS NOT RECEIVED, A PROPER ANALYSIS CANNOT BE PERFORMED. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE CASSETTE, WITHOUT CLOSED SAMPLES OR A CASSETTE WITH THE DATE OF CASSETTE'S OPENING WRITTEN AND WITHIN THE 6 MONTHS AFTER OPENING, A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SAFIL VIOLET SUTURE. A VETERINARY CUSTOMER REPORTED THAT THE THREAD BREAKS WHILE KNOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281162 SAFIL C VIOLET 2 (5) 15M SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. F1038107 117242

    Patients

    Seq Age Sex Outcome Treatment
    1