BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 3/0 (2) 90CM 2XHRC26 CV

    MDR report key: 8744365 · Received June 28, 2019

    Report

    Report Number
    3003639970-2019-00514
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 28, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K980703 SAMPLES RECEIVED: THERE ARE NO SAMPLES/BATCH NUMBER AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS RECEIVED, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REMARKS: WHEN WORKING WITH SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS, DOES NOT CAUSE THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED. FINAL CONCLUSION: WITHOUT SAMPLES, WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THE THREAD BREAKS AND THE NEEDLE DETACHES EASILY. THIS OCCURRED DURING AN ABDOMINAL AORTA ANEURYSM PROCEDURE WHEN SUTURING THE AORTA USING DACRON PROTHESIS. THIS CREATED UNCERTAINTY IN THE SUTURE. NO PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536874 PREMILENE 3/0 (2) 90CM 2XHRC26 CV CARDIAC SUTURE GAW B.BRAUN SURGICAL SA C2090812

    Patients

    Seq Age Sex Outcome Treatment
    1