BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 5/0 (1) 45CM DS12 (M) POW

    MDR report key: 6487877 · Received April 12, 2017

    Report

    Report Number
    3003639970-2017-00193
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: THREE UNUSED UNITS ARE RECEIVED, IN ORIGINAL CLOSED PACKAGING. PRELIMINARY ANALYSIS: · STOCK REVIEW: STOCK IS NOT AVAILABLE FOR THIS PRODUCT CODE AND LOT NUMBER. · QUANTITY PRODUCED / IMPORTED: THIS PRODUCT CODE AND BATCH NUMBER WERE MANUFACTURED (B)(4) UNITS. · DISTRIBUTED QUANTITY: THE UNITS MANUFACTURED WERE DISTRIBUTED TO (B)(4) CLIENTS FROM DIFFERENT CITIES OF THE NATIONAL TERRITORY ((B)(6)). · BACKGROUND: THE DATABASE OF COMPLAINTS WAS REVIEWED AND IT WAS VERIFIED THAT TO DATE THERE ARE NO REPORTS RELATED TO THIS PRODUCT CODE AND LOT NUMBER. · BATCH RECORD: THE DOCUMENTATION CORRESPONDING TO THE MANUFACTURE OF THE LOT WAS REVISED AND NO DEVIATIONS OR ALTERATIONS WERE EVIDENCED DURING THE PROCESS. · RESULTS FOR BATCH RELEASE: ARRAY RESISTANCE ANALYZES FOR BATCH RELEASE, MET THE REQUIREMENTS OF THE USP AND B. BRAUN REQUIREMENTS FOR THIS SUTURE GAUGE. ANALYSIS OF SAMPLE (S): THE UNITS RECEIVED IN ORIGINAL CLOSED PACKAGE, WERE SUBMITTED TO A TEST OF RESISTANCE TO THE ASSEMBLY AND IT WAS VERIFIED THAT THE DATA OBTAINED IN THE ANALYSIS, COMPLY WITH THE REQUIREMENTS FOR THIS TYPE SUTURE. CONCLUSIONS: BASED ON THE ANALYSES PERFORMED, THE CLAIM IS DETERMINED AS "NOT JUSTIFIED", SINCE THE RESULTS OF THE ANALYZES IN THE SAMPLES RECEIVED MEET THE SPECIFICATIONS. ALTHOUGH THE RESULTS OF CLOSED SAMPLES RECEIVED MEET THE OEM SPECIFICATION, NOTE THIS INCIDENT IS TAKEN IN ORDER TO ASSESS WHETHER NEW OR ADDITIONAL MEASURES ARE REQUIRED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE THREAD DETACHED FROM THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270327 PREMILENE 5/0 (1) 45CM DS12 (M) POW SUTURES GAW B.BRAUN SURGICAL SA C0095279 516114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other