BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK UNDY 3/0(2)70CM DSMP24MDDP

    MDR report key: 8946254 · Received August 29, 2019

    Report

    Report Number
    3003639970-2019-00621
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 17, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED A CLOSED SAMPLE FOR ANALYSIS. TIGHTNESS TEST TO THE SAMPLE RECEIVED HAS BEEN PERFORMED AND THE UNIT IS TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). 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.

    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 IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THREAD BREAKS. THE REPORTER INDICATED THAT DURING A MAXILLOFACIAL SURGICAL PROCEDURE THE THREAD BROKE ON SEVERAL OCCASIONS DURING TH USE OF 2 BOXES. PER THE REPORTER THE SURGEON HAS USED THIS SUTURE FOR MANY MONTHS AND NO PROBLEMS OCCURRED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739310 NOVOSYN QUICK UNDY 3/0(2)70CM DSMP24MDDP SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA G3046657 119093

    Patients

    Seq Age Sex Outcome Treatment
    1