BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8153237 · Received December 11, 2018

    Report

    Report Number
    3003639970-2018-00758
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 7, 2019
    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

    WE HAVE RECEIVED 48 CLOSED SAMPLES TO ANALYZE THIS CASE AND CC 400411534. TIGHTNESS TEST TO THE SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF ALL SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 2.08 KGF IN AVERAGE AND 0.71 KGF IN MINIMUM (EP REQUIREMENTS: 1.12 KGF IN AVERAGE AND 0.46 KGF IN MINIMUM). 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. ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS. BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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 · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 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. G.5: SIMILAR PRODUCT ON US MARKET IS REGISTERED UNDER 510(K): K122734

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE THREAD DURING SUTURING OF A PERITONEAL TEAR. THE TISSUE TYPE BEING SUTURED WERE CUTANEOUS AND VAGINA. THERE WAS NO NEGATIVE CONSEQUENCE TO THE PATIENT. THE CURRENT STATE OF PATIENT IS REPORTED AS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991043 NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP SUTURE GAM B. BRAUN SURGICAL SA C3046651 118266

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR