BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0(2) 4X45CM HR22TO (M)

    MDR report key: 3844789 · Received March 12, 2014

    Report

    Report Number
    2916714-2014-00123
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Report Date
    March 5, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR SITE EVAL: SAMPLES RECEIVED 1 OPEN POUCH. THIS IS THE SECOND COMPLAINT OF THIS CODE/BATCH FOR THE SAME ISSUE. THERE ARE NO UNITS IN OEM STOCK. WE HAVE RECEIVED 1 OPEN SAMPLE WITH ONLY ONE SUTURE INSIDE THE PACK. THERE SHOULD HAVE BEEN PRESENTED FOUR SUTURES INSIDE, AS THE PRODUCT DESCRIPTION. OBSERVING BY THE MICROSCOPE, WE COULD SEE THAT THERE WERE NO CLEAR MARKS OF NEEDLES ON THE SUPPORT CARDBOARD. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. WE CONSIDER THAT THIS IS AN ISOLATED AND ACCIDENTAL UNIT AND THAT THE WHOLE BATCH IS CORRECT. WE WILL TAKE NOTE OF THIS INCIDENCE. REMARKS: THE COMPLAINT IS JUSTIFIED FOR ISOLATED UNITS, BUT THE CONCLUSION IS "NOT CORRESPONDING", ACCORDING TO THE IN PROCESS SELF CONTROL RESULTS WHEN THIS BATCH WAS MADE. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTION ON PRODUCT: NA. CORRECTIVE/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PACKAGE WAS NOT COMPLETE. IT CONTAINED 1 THREAD INSIDE INSTEAD OF 4. THE BATCH CODE OF THIS SAMPLE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149362 NOVOSYN VIOLET 3/0(2) 4X45CM HR22TO (M) GAM B. BRAUN SURGICAL S.A. C0088730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other