BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 6/0 (0.7) 45CM DSMP11 (M)

    MDR report key: 8781337 · Received July 11, 2019

    Report

    Report Number
    3003639970-2019-00530
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Report Date
    July 11, 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. INVESTIGATION: SAMPLES RECEIVED: 2 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 2,196 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED TWO CLOSED SAMPLES TO ANALYZE THIS COMPLAINT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.36 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM (EP REQUIREMENTS: 0.15 KGF IN AVERAGE AND 0.06 KGF IN MINIMUM). WE HAVE ALSO TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.33 KGF IN AVERAGE AND 0.33 KGF IN MINIMUM (EP REQUIREMENTS: 0.17 KGF IN AVERAGE AND 0.082 KGF IN MINIMUM). 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, DOES NOT CAUSE THE MATERIAL TO BE DAMAGED BY BEING PINCHED OR KINKED. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES 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. 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 THE THREAD TEARS OFF. THE REPORTER INDICATED THAT DURING SURGERY THE THREAD BREAKS OR DETACHES FROM THE NEEDLE. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574632 DAFILON BLUE 6/0 (0.7) 45CM DSMP11 (M) OTHER SUTURE GAR B.BRAUN SURGICAL SA C0936022 618471

    Patients

    Seq Age Sex Outcome Treatment
    1