BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2 (5) 90CM HR48 (M)

    MDR report key: 3810517 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00254
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 16, 2014
    Manufacturer
    B.BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED. ALL PACKS RECEIVED ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. TESTED THE LINEAR PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS ARE WITHIN SPECIFICATION. CHECKED THE BATCH MFG RECORD AND THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE IN PROCESS CONTROLS FULFILLED OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE THREAD BROKE MULTIPLE TIMES. STRONG BLEEDING AND RISKS OF LOOSING THE UTERUS WERE POSSIBLE. THE REPORTED EVENT INCLUDES 3 TYPES OF SUTURES WITH 4 DIFFERENT LOT NUMBERS. A SEPARATE FORM IS BEING FILED ON EACH AS THE INFO PROVIDED DOES NOT INDICATE IF ALL SUTURES WERE FROM ONE EVENT, OR MULTIPLE EVENTS WITH SAME DESCRIPTION OCCURRED. OTHER 3 ARE: 2916714-2014-00252/ 2916714-2014-00253 / 2916714-2014-00255.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233392 NOVOSYN VIOLET 2 (5) 90CM HR48 (M) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B.BRAUN SURGICAL S.A. C0068563 114054

    Patients

    Seq Age Sex Outcome Treatment
    1