BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON GREEN 2/0 (3) 30CM SKR19(M)

    MDR report key: 9661761 · Received February 3, 2020

    Report

    Report Number
    3003639970-2020-00060
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAT
    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

    INVESTIGATION: SAMPLES RECEIVED: 3 UNOPENED POUCHES AND 1 OPENED. WE HAVE ALSO RECEIVED AN OPEN POUCH OF THE SAME REFERENCE BUT OF ANOTHER BATCH TO COMPARE (HOWEVER, THE PART WHERE THE BATCH APPEARS IS MISSING). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 3 CLOSED SAMPLES AND 1 OPEN AND UNUSED SAMPLE MARKED AS "NEW" OF THE INVOLVED BATCH FOR ANALYSIS. WE HAVE ALSO RECEIVED AN OPEN POUCH OF THE SAME REFERENCE BUT OF ANOTHER BATCH TO COMPARE MARKED AS "OLD" (THE BATCH NUMBER OF THIS SAMPLE IS NOT KNOWN DUE TO THE PART WHERE THE BATCH APPEARS IS MISSING). THE NEEDLES OF ALL SAMPLES RECEIVED HAVE BEEN TESTED FOR BENDING STRENGTH AND THE RESULTS FULFILL PRODUCT SPECIFICATIONS (MINIMUM BENDING STRENGTH SPECIFICATION FOR THIS NEEDLE: > 10.8 NXCM): 15.66 NXCM IN MINIMUM FOR THE OPEN SAMPLE RECEIVED MARKED AS "NEW". 14.27 NXCM IN MINIMUM FOR THE OPEN SAMPLE RECEIVED MARKED AS "OLD". 15.38 NXCM IN MINIMUM FOR THE CLOSED SAMPLES RECEIVED. THE NEEDLES OF THE CLOSED SAMPLES RECEIVED HAVE ALSO BEEN TESTED FOR NEEDLE PUNCTURE STRENGTH AND THE RESULTS FULFILS THE SPECIFICATION (<0.320N): THE AVERAGE PENETRATION RESULT IS 0.298 N. THE NEEDLE PUNCTURE STRENGTH CANNOT BE PERFORMED WITH OPEN SAMPLES. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL THE SPECIFICATIONS: NEEDLE BENDING STRENGTH OF SAMPLES TESTED DURING PRODUCTION WAS 11.51 NXCM IN MINIMUM (MINIMUM BENDING STRENGTH SPECIFICATION FOR THIS NEEDLE: > 10.8 NXCM). THE AVERAGE PENETRATION RESULT OF SAMPLES TESTED DURING PRODUCTION WAS 0.263N (MAXIMUM PUNCTION STRENGTH SPECIFICATION FOR THIS NEEDLE: <0.320 N). ON THE OTHER HAND, WE HAVE CHECKED THE NEEDLE DIMENSIONS OF THE SAMPLES MARKED AS "OLD" AND "NEW" AND BOTH NEEDLES COMPLY THE SPECIFICATIONS OF THE PRODUCT. EACH SAMPLE CONTAINS ONE DIFFERENT NEEDLE REFERENCE. BOTH NEEDLE REFERENCES ARE APPROVED TO BE USED IN THIS PRODUCT. THE NEEDLES OF THE SAMPLES RECEIVED ARE ACCORDING TO THE DESIGN AND THE ASPECT IS THE CORRECT ONE. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE 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.

    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. INVESTIGATION: SAMPLES RECEIVED: 12 UNOPENED RACE PACKS. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH REGARDING OTHER ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 3,168 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 12 CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 3.16 KGF IN AVERAGE AND 2.83 KGF IN MINIMUM (EP REQUIREMENTS: 1.79 KGF IN AVERAGE AND 0.91 KGF IN MINIMUM). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. REMARKS: WHEN WORKING WITH MONOSYN 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: 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 THAT THE BENDING OF THE NEEDLE IS DIFFERENT. THE REPORTER INDICATED THAT THE BENDING OF THE NEEDLE IS DIFFERENT IN COMPARISON TO ANOTHER SAMPLE. DUE TO THIS FACT THE NEEDLE IS SHARPER. THIS EVENT OCCURRED DURING A NASAL SEPTUM PROCEDURE. THERE WAS NO DELAY AND THE PATIENT OUTCOME WAS GOOD. THERE IS NO PATIENT DATA AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125117 PREMICRON GREEN 2/0 (3) 30CM SKR19(M) OTHER SUTURE GAT B.BRAUN SURGICAL SA C0026536 119234V004

    Patients

    Seq Age Sex Outcome Treatment
    1