BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2 (5) 4X70CM HR37STO (M)

    MDR report key: 3850360 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00152
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 28, 2014
    Report Date
    March 17, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: SAMPLES REC'D: 4 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKS REC'D ARE TIGHT. THE NEEDLE ATTACHMENT OF THE SAMPLES REC'D WAS TESTED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. NEEDLE ATTACHMENT RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE WITHIN SPECIFICATIONS. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD DETACHED VERY FAST AND EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160656 NOVOSYN VIOLET 2 (5) 4X70CM HR37STO (M) SUTURE GAM B. BRAUN SURGICAL S.A. B0088698 112291V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other