BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14521726 · Received May 27, 2022

    Report

    Report Number
    3003639970-2022-00209
    Event Type
    Malfunction
    Date Received
    May 27, 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. G4: PMA/510(K) NUMBER ADDED: K122734. 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 5 CLOSED SAMPLES FOR ANALYSIS. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WHEN WE HAVE CONDUCTED ROTATION TEST IN CLOSED SAMPLES RECEIVED, WE HAVE NOTICED THAT ONE OF THE THREADS (1 OF 5 SAMPLES TESTED) BREAK EASILY NEXT TO THE NEEDLE. THE DETACHMENT OF THE NEEDLE OCCURS BY TOO MUCH THERMAL TREATMENT APPLIED TO THE THREAD ENDS WHICH CAUSES THAT THE THREAD BURNS AND BREAKS EASILY IN THE ATTACHMENT AREA. 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: TAKING INTO ACCOUNT THAT THE RESULTS OF THE SAMPLES RECEIVED DO NOT FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. 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: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE. MOREOVER, TRAINING REGARDING THIS ISSUE TO PRODUCTION PERSONNEL WAS DONE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CLIENT REPORTED THAT THE NEEDLE AND THE THREAD SEEMED TO BE POORLY ATTACHED AND SOME OF THE SUTURES GOT DETACHED RIGHT AFTER TAKING THEM OUT OF THE PACKAGE. SOME GOT DETACHED WHEN THE SURGEON HAD TAKEN A COUPLE OF STITCHES. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764092 NOVOSYN VIOLET 4/0 (1,5)45CM DS19 (M)RCP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C0068220 121295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown