BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 5/0 (1) 45CM DS12 (M)

    MDR report key: 8707257 · Received June 18, 2019

    Report

    Report Number
    3003639970-2019-00477
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    June 18, 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

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. 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. K980704. INVESTIGATION: SAMPLES RECEIVED: 21 UNOPENED POUCHES AND 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND MOSTLY DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE (B)(4) UNITS IN OUR STOCK. WE HAVE RECEIVED 21 CLOSED SAMPLES AND ONE OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD, AND THE THREAD IS STILL WOUND ON THE PACK. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT OF THE 21 CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP):(B)(4). 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: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THREAD DETACHED. THE REPORTER OF THE UROLOGY DEPARTMENT INDICATED THAT TWO PIECES OF THREAD DETACHED FROM THE NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501707 SAFIL VIOLET 5/0 (1) 45CM DS12 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1048207 118424

    Patients

    Seq Age Sex Outcome Treatment
    1