BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 4/0 (1,5)45CM DS19 (M)RCP

    MDR report key: 14432864 · Received May 18, 2022

    Report

    Report Number
    3003639970-2022-00212
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Report Date
    June 30, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICE OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S., K122734. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4: MODEL AND CATALOG NUMBER CORRECTION: C0068220 INSTEAD OF C0068220N1. LOT NUMBER AND EXPIRATION DATE ADDED: 121192; 05/11/2026. G4: PMA/510(K) NUMBER ADDED: K122734. H4: DEVICE MANUFACTURER DATE ADDED: 05/11/2021. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 5,976 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 1 CLOSED SAMPLE TO ANALYZE THIS COMPLAINT. TIGHTNESS TEST TO THE CLOSED SAMPLE RECEIVED HAS BEEN PERFORMED AND THE UNIT IS TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLE RECEIVED AND THE RESULT FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.58 KGF IN AVERAGE AND IN MINIMUM (EP REQUIREMENTS: 0.46 KGF IN AVERAGE AND 0.23 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. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLE 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CLIENT REPORTED THAT THE THREAD AND THE NEEDLE ARE NOT CONSISTENTLY ATTACHED AND THEREFORE SOME SUTURES GET DETACHED RIGHT AFTER TAKING THEM OUT OF THE PACKAGE AND SOME GET DETACHED WHEN THE SURGEON HAS TAKEN A COUPLE OF STITCHES. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342953 NOVOSYN VIOLET 4/0 (1,5)45CM DS19 (M)RCP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C0068220 121192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown