BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM

    MDR report key: 9643404 · Received January 29, 2020

    Report

    Report Number
    3003639970-2020-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    January 29, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. K012201. SAMPLES RECEIVED: THERE ARE NO SAMPLES/BATCH NUMBER AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS AVAILABLE, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLE OR MORE INFORMATION WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. 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 AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE 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 · 1

    IT WAS REPORTED THAT THE NEEDLE IS HARD TO DETACH FROM THE THREAD. THE REPORTER INDICATED THAT THE NEEDLE IS HARD TO DETACH FROM THE THREAD. PER THE REPORTER, IT IS ASSUMED THAT THE ARMORING IS TOO STRONG AS TOO MUCH STRENGTH IS REQUIRED TO PULL NEEDLE FROM THE THREAD. THIS WAS IN COMPARISON TO ANOTHER VENDOR'S SUTURE. PATIENT DATA AND ADDITIONAL EVENT DETAILS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106345 PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM CARDIAC SUTURE GAT B.BRAUN SURGICAL SA C0026477

    Patients

    Seq Age Sex Outcome Treatment
    1