BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    160-R SKINMARKER REGULAR

    MDR report key: 6149581 · Received December 6, 2016

    Report

    Report Number
    9612030-2016-00783
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    November 2, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. ONE UNUSED SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS TESTED BY A VISUAL INSPECTION AND THE REPORTED CONDITION WAS CONFIRMED. THE REVIEW OF DEVICE HISTORY RECORD (DHR) INDICATED THAT DURING THE PRODUCTION PROCESS, THE ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN THE ACCEPTABLE LIMITS. PRODUCT ANALYSIS CONFIRMED THAT ALL THE PROCEDURES WERE BEING FOLLOWED ACCORDINGLY. THE PROBABLE ROOT CAUSE OF THE REPORTED CONDITION INDICATED BLOCKED BARREL VENTS WHICH MAY BE CAUSED BY THE DEFECTIVE CORE PINS. AS THE PURPOSE OF THE VENT IS TO EQUALIZE THE PRESSURE FROM THE INSIDE TO THE OUTSIDE OF THE PEN, IT MAY CAUSE LEAKAGE OF PEN AS THE VENT IS BLOCKED. THE CUSTOMER HAS ATTACHED THE PICTURE OF THE REPORTED CONDITION. CORRECTIVE ACTIONS LIKE PREPARING, INSPECTING AND PACKAGING BARRELS WERE RELEASED TO CHANGE THE INSPECTION CRITERIA FOR BLOCKED BARREL VENTS. OPERATORS AND QUALITY INSPECTORS WERE TRAINED ON THE WORK INSTRUCTIONS AND THE NEW INSPECTION CRITERIA WHICH ALLOWS A PASSING RESULT IF TWO OR MORE VENTS ARE OPENED AND IF THERE IS PARTIAL VENTING, AN ADDITIONAL VISUAL INSPECTION IS PERFORMED BY INSERTING A NIB IN THE BARREL. THE QUALITY DEPARTMENT REVIEWS AND INSPECT THE PREVENTATIVE MAINTENANCE/REPAIR OF THE MOLDING TOOL AND IDENTIFIES WHAT ISSUES NEED TO BE ADDRESSED WHEN THE TOOL IS SENT OUT FOR REPAIR/MAINTENANCE AND MAKE SURE THAT ALL AND ANY NON-CONFORMANCES WERE ADDRESSED DURING MAINTENANCE AND REPAIR. THE REVIEW OF CUSTOMER COMPLAINTS AND IN-HOUSE NON-CONFORMANCES WILL BE PERFORMED TO ENSURE EFFECTIVENESS OF THE PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH A SKIN MARKER. THE CUSTOMER REPORTS INK LEAKED INSIDE PRODUCT. UPON SAMPLE EVALUATION ON 11/11/2016, THIS LOT NUMBER WAS FOUND TO BE AFFECTED.

    Description of Event or Problem · 1

    CUSTOMER STATES: INK LEAKED INSIDE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797673 160-R SKINMARKER REGULAR SKIN MARKER FZZ COVIDIEN 31145785 5238100664X

    Patients

    Seq Age Sex Outcome Treatment
    1