BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE NON-CARDIOVASCULAR

    MDR report key: 7281208 · Received February 19, 2018

    Report

    Report Number
    3003639970-2018-00098
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Report Date
    February 16, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. COMPLAINT DESCRIPTION: THE NEEDLE SEPARATES FROM THE FIBER WITHOUT MORE PULLING ON THE MATERIAL. SAMPLES RECEIVED: 13 UNOPENED REPACK AND 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED 13 CLOSED SAMPLES, ONE OPEN AND USED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD AND A DETACHED NEEDLE. TESTED THE NEEDLE ATTACHMENT OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS DO NOT FULFILL THE REQUIREMENTS OF THE OEM. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFILL THE SPECIFICATIONS OF THE OEM SPECIFICATIONS, CONCLUDE THAT THE COMPLAINT IS JUSTIFIED.

    Description of Event or Problem · 0

    CZECH REPUBLIC. THE NEEDLE SEPARATES FROM THE FIBER WITHOUT MORE PULLING ON THE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123292 PREMILENE NON-CARDIOVASCULAR SUTURES GAW B.BRAUN SURGICAL SA B2095674 117102V014

    Patients

    Seq Age Sex Outcome Treatment
    1