BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 4/0 (1.5) 45CM DS16 (M)

    MDR report key: 5542785 · Received April 1, 2016

    Report

    Report Number
    2916714-2016-00214
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Report Date
    March 31, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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: 15 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH, THERE ARE NO UNITS IN STOCK. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFILLS THE OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLS THE OEM REQUIREMENTS. AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "WHEN WORKING WITH SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS FORCEPS AND NEEDLE HOLDERS, DO NOT CAUSE ANY CRUSHING OR CRIMPING DAMAGE TO THE SUTURE MATERIAL". FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. RESULTS OF THE SAMPLES RECEIVED FULFILLS THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. ACTIONS ON PRODUCT: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO TAKE AN ACTION ON DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO THE INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. 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: (B)(6). THE THREAD TEARS DURING SUTURING. (NO DETACHMENT OF THE NEEDLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196803 DAFILON BLUE 4/0 (1.5) 45CM DS16 (M) SUTURES GAR B.BRAUN SURGICAL SA C0933139 614427V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other