BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 2/0 (3) 75CM DS24 (M)

    MDR report key: 8750260 · Received July 1, 2019

    Report

    Report Number
    3003639970-2019-00513
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 1, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    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 · 1

    PMA/510K: 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. K990090. SAMPLES RECEIVED: THERE ARE NO SAMPLES OR INVOLVED 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 CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REMARKS: WHEN WORKING WITH DAFILON SUTURE MATERIALS GREAT CARE SHOULD BE TAKEN TO ENSURE THAT THE USE OF SURGICAL INSTRUMENTS, SUCH AS TWEEZERS AND NEEDLE HOLDERS DO NOT DAMAGE THE MATERIAL 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 CAPA NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREAD BROKE AND SPLICED. THE REPORTER INDICATED THAT THE THREAD BROKE AND "SPLICED" EASILY. NO PATIENT INFORMATION OR TYPE OF SURGICAL PROCEDURE HAS BEEN PROVIDED. PATIENT OUTCOME WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541675 DAFILON BLUE 2/0 (3) 75CM DS24 (M) OTHER SUTURE GAR B.BRAUN SURGICAL SA C0933406

    Patients

    Seq Age Sex Outcome Treatment
    1