BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 8/0 (0.4) 60CM 2XDR6 (M)CV

    MDR report key: 6159555 · Received December 9, 2016

    Report

    Report Number
    2916714-2016-01000
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 9, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 175 UNOPENED RACEPACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. TESTED THE NEEDLE ATTACHMENT OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE OEM REQUIREMENTS REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED THE OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. RESULTS OF THE SAMPLES RECEIVED FULFILLS THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENT IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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 · 0

    COUNTRY OF COMPLAINT: RUSSIAN FED. IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808186 PREMILENE 8/0 (0.4) 60CM 2XDR6 (M)CV SUTURES GAW B.BRAUN SURGICAL SA C2090712 115195

    Patients

    Seq Age Sex Outcome Treatment
    1 Other