BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 3/0 (2) 45CM DS24

    MDR report key: 5822080 · Received July 26, 2016

    Report

    Report Number
    2916714-2016-00571
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    June 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    K151165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUOUS OF SECTION G5 PREVIOUSLY FILED UNDER 510(K) K990090. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: AUSTRALIA. THE SUTURES BROKE DURING TYING OF THE KNOT. ONE PATIENT HAD 4 SUTURES USED, THE FIRST THREE BROKE, THE 4TH SUTURE WAS USED. THIS PATIENT HAD AN INFECTION POST IMPLANTATION, BUT THE CAUSE HAS NOT BEEN PROVEN.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 15 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH, (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET, THERE ARE NO UNITS IN STOCK. 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 FULFILLS THE OEM REQUIREMENTS. STERILIZATION PROCESS WAS ALSO NORMAL AND THE RESULTS OF THE STERILIZATION CONTROL ARE CORRECT. AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "SIDE EFFECTS: AS FOR EVERY OTHER SUTURE MATERIAL, PROLONGED CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE CAN LEAD TO LITHIASIS. THE FOLLOWING SIDE EFFECTS MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT: TISSUE INJURY, TRANSITORY LOCAL IRRITATION, TRANSIENT INFLAMMATORY FOREIGN BODY REACTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, HYPERTROPHIC SCAR/GRANULOMA FORMATION, TRACK BLEEDING, INCREASED RISK OF ANEURISM AND STENOSIS. IN RARE CASES HYPERSENSITIVITY OR ALLERGIC REACTION TO THE SUTURE MATERIAL WERE OBSERVED." FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. ALTHOUGH THE 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475643 DAFILON BLUE 3/0 (2) 45CM DS24 SUTURES GAR B.BRAUN SURGICAL SA C0932353 615403

    Patients

    Seq Age Sex Outcome Treatment
    1 Other