BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2 (5) 4X4CM HR 48TO (M)

    MDR report key: 3880726 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00411
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 28, 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. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 16 OPEN UNIT. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. WE HAVE RECEIVED 16 OPEN SAMPLES AND 9 OF THEM HAS THE FIRST PACK SEALED TO SECOND PACK IN THE 4TH SEALING. THIS IS DUE TO AN ACCIDENTAL EFFECT IN THE WELDING MACHINE AND THIS UNIT WAS NOT SORTED OUT BY THE PERSONNEL INVOLVED IN THIS PROCESS. THIS IS AN ACCIDENTAL AND ISOLATED INCIDENT AND THE WHOLE BATCH IS NOT EFFECTED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: OEM HAS OPENED CORRECTIVE ACTION TO AVOID THIS IN THE FUTURE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INNER FOIL WAS WELDED WITH OUTER FOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314184 NOVOSYN VIOLET 2 (5) 4X4CM HR 48TO (M) SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A. B0088788 113475V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other