BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 1 (4) 90CM HR37S (M)

    MDR report key: 9216124 · Received October 21, 2019

    Report

    Report Number
    3003639970-2019-00724
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 25, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 4 OPEN POUCHES. 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 FOUR OPEN AND UNUSED SAMPLES FOR ANALYSIS. WE HAVE CHECKED THE THREAD SURFACE ON THE SAMPLES RECEIVED AND IS CORRECT AND THE USUAL ONE AS CAN BE SEEN IN ENCLOSED PICTURE. THE THREADS ARE NOT DAMAGED AND NO DEFECTS HAVE BEEN FOUND. 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 SAMPLES RECEIVED FULFIL 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

    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. K122734. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREAD IS FRAYED. THE REPORTER INDICATED THAT WHEN OPENING THE PACKAGE THE PHYSICIAN CAN SEE FRAYED THREAD. PER THE REPORTER, THE EVENT OCCURRED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008502 NOVOSYN VIOLET 1 (4) 90CM HR37S (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0068597 119126

    Patients

    Seq Age Sex Outcome Treatment
    1