BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 2/0 (3)70CM HS26S(M).

    MDR report key: 6415059 · Received March 17, 2017

    Report

    Report Number
    3003639970-2017-00120
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 17, 2017
    Report Date
    March 16, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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: 2 UNOPENED AND 1 OPENED POUCHES. 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 TWO CLOSED SAMPLES AND ONE OPEN AND USED SAMPLE WITH THE THREAD BROKEN. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH 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 FULFILL THE OEM REQUIREMENTS. REMARKS: "WHEN WORKING WITH MONOPLUS® SUTURE MATERIAL, GREAT CARE SHOULD BE TAKEN IN ORDER TO ENSURE THAT THE SURGICAL INSTRUMENTS USED, SUCH AS FORCEPS OR NEEDLE HOLDERS DO NOT CAUSE ANY CRUSHING OR CRIMPING DAMAGE TO THE SUTURE MATERIAL. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFILL THE OEM SPECIFICATIONS, NOTE OF THIS INCIDENT IS TAKEN 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: SPAIN. IT WAS REPORTED THAT THE THREAD BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196595 MONOPLUS VIOLET 2/0 (3)70CM HS26S(M). SUTURES NEW B.BRAUN SURGICAL SA G0024186ESV 116184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other