BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 2/0 (3) 90CM DS30

    MDR report key: 7931692 · Received October 3, 2018

    Report

    Report Number
    3003639970-2018-00633
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Report Date
    January 31, 2019
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAR
    PMA / PMN Number
    K990090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. INVESTIGAITON ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A CLOSED AND AN OPEN AND USED SAMPLE. THE OPEN SAMPLE RECEIVED IS A USED SUTURE WITH A BROKEN THREAD, IN CONSEQUENCE NO FURTHER ANALYSIS CAN BE DONE. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLE RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 3.98 KGF (EP REQUIREMENTS: 1.53 KGF IN AVERAGE AND 0.92 KGF IN MINIMUM). WE HAVE ALSO TESTED THE LINEAR PULL TENSILE STRENGTH OF THE CLOSED SAMPLE RECEIVED AND THE RESULT IS 4.51 KGF. THIS VALUE IS CORRECT AND USUAL FOR THIS THREAD AND SIZE (THERE ARE NO EP LIMITS FOR THIS TEST). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 3.61 KGF IN MINIMUM AND 3.98 KGF IN AVERAGE (EP REQUIREMENTS: 1.53 KGF IN AVERAGE AND 0.92 KGF IN MINIMUM). ALTHOUGH THE RESULTS OF THE CLOSED SAMPLE RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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. ASSOCIATED MEDWATCH: 3003639970-2018-00641.

    Description of Event or Problem · 0

    DURING A MID-THIGH AMPUTATION, AT THE SECOND PASSAGE, THE WIRE BROKE DURING CUTANEOUS PASSAGE. THE WIRE APPEARED TO BE BURNED AT THE BREAKAGE POINT, THERE WAS NO ELECTRIC BISTOURY (KNIFE) JUST PRIOR TO THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771142 DAFILON BLUE 2/0 (3) 90CM DS30 SUTURE GAR B. BRAUN SURGICAL S.A. C0935522 618024

    Patients

    Seq Age Sex Outcome Treatment
    1