BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 0 (3.5) 70CM FR26 (M)

    MDR report key: 9766116 · Received February 27, 2020

    Report

    Report Number
    3003639970-2020-00111
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    January 30, 2020
    Report Date
    May 11, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION - ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FROM THE CUSTOMER FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULT DURING THE PROCESS FULFILL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. 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. NO CAPA IS NECESSARY.

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS AN ISSUE WITH NEEDLE DETACHMENT. THE REPORTER INDICATED THAT THE NEEDLE DETACHED FROM THE THREAD WHEN PULLING. PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228315 NOVOSYN VIOLET 0 (3.5) 70CM FR26 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C0068416 119193

    Patients

    Seq Age Sex Outcome Treatment
    1