BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTEC SPG 4X8 NON ST 10S 16PLY

    MDR report key: 6071072 · Received November 1, 2016

    Report

    Report Number
    1018120-2016-00161
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 22, 2016
    Manufacturer
    AUGUSTA
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE WAS NO LOT NUMBER PROVIDED WITH THIS COMPLAINT, THEREFORE IT WAS NOT POSSIBLE TO COMPLETE A REVIEW OF THE LOT HISTORY. THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED WITHOUT AN ACTUAL SAMPLE TO EXAMINE. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS INITIATED TO ADDRESS THE MISCOUNT COMPLAINTS FOR VISTEC PRODUCTS. DURING THIS CAPA, THE OFF LINE BANDING EQUIPMENT WAS DISCONTINUED. A REVERSAL OF THE AUTOBANDER TRAYS WAS PERFORMED TO TIGHTEN THE BANDS. AN ADDITIONAL CAPA HAS BEEN OPENED TO OPTIMIZE THE AUTOBANDER PROCESS IN WHICH THE PRODUCT SPECIFICATION HAS BEEN UPDATED TO INCLUDE THIS COMPLAINT TYPE AND IDENTIFY THE OCCURRENCE. A ROTATION OF STACKED SPONGES WILL BE REMOVED FROM THE PROCESS AND VALIDATION ACTIVITIES WILL BE PERFORMED. THIS CAPA IS CURRENTLY IN THE IMPLEMENTATION STAGE. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS. THE PRODUCTION DEPARTMENT WILL BE NOTIFIED OF THIS INCIDENT WITH A COPY OF THIS COMPLAINT RESPONSE. FINISHED GOODS TESTING IS CURRENTLY BEING PERFORMED AT A HEIGHTEN LEVEL FOR PRODUCTS PACKAGED USING BANDED 10 UNITS FOR MISCOUNT. THIS HEIGHTENED TESTING IS PERFORMED TO ENSURE CONTAINMENT FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE PAD. THE CUSTOMER REPORTS MISCOUNT OF GAUZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722668 VISTEC SPG 4X8 NON ST 10S 16PLY GAUZE SPONGE EFQ AUGUSTA 7463 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1