BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 4/0 (1.5)70CM DS19 (M)

    MDR report key: 8333796 · Received February 12, 2019

    Report

    Report Number
    3003639970-2019-00097
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Report Date
    February 12, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: WE HAVE RECEIVED 5 CLOSED SAMPLES OF EACH POSSIBLE BATCH, 118062 AND 118404. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS FROM THESE CODE BATCHES; THERE ARE NO UNITS IN OUR STOCK. ALL SAMPLES RECEIVED ARE TIGHT. WE HAVE TESTED THE NEEDLE ATTACHMENT STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). REVIEW OF THE BATCH MANUFACTURING RECORD SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT RESULTS BEFORE RELEASING THE PRODUCT WERE 1.07 KGF IN AVERAGE AND 0.85 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES 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. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE SUTURE. DURING USE ON A PATIENT AT A DENTAL CLINIC, THE SUTURE DETACHED FROM THE NEEDLE. IT WAS UNCLEAR FROM WHICH SUTURE BOX THE PACK HAD BEEN TAKEN AND OPENED. IT WAS NOTED THAT IT WAS UNKNOWN WHETHER THERE WAS PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124971 NOVOSYN VIOLET 4/0 (1.5)70CM DS19 (M) SYNTHETIC ABSORBABLE BRAIDED GAM B.BRAUN SURGICAL SA C0068420

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR