BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M)

    MDR report key: 3850422 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00168
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 14, 2014
    Report Date
    March 18, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 5 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKS RECEIVED ARE TIGHT. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEW THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. REMARKS: THE COMPLAINT IS JUSTIFIED FOR ISOLATED DETACHED NEEDLES, BUT THE CONCLUSION IS NOT CORRESPONDING ACCORDING TO THE RESULTS OF THE SAMPLES TESTED. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/ PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). NEEDLE AND THREAD DETACHMENT. THIS HAS HAPPENED IN DIFFERENT GYN PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159846 NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M) ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. C0068047 113441

    Patients

    Seq Age Sex Outcome Treatment
    1 Other