BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP

    MDR report key: 11775972 · Received May 5, 2021

    Report

    Report Number
    3003639970-2021-00174
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Report Date
    September 13, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. 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 ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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.

    Additional Manufacturer Narrative · 1

    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. PMA/510K: K170661. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT THREAD IS BROKEN WHEN SUTURING AND KNOTTING. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671835 NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C3046651 120411

    Patients

    Seq Age Sex Outcome Treatment
    1