BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENT PACK

    MDR report key: 5717029 · Received June 10, 2016

    Report

    Report Number
    3005011024-2016-00008
    Event Type
    Malfunction
    Date Received
    June 10, 2016
    Date of Event
    May 12, 2016
    Report Date
    June 10, 2016
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE ROOT CAUSE WAS DETERMINED TO BE A PULLING ERROR. THE EMPLOYEE RESPONSIBLE FOR PULLING THE REQUIRED GAUZE WENT TO THE INCORRECT BIN LOCATION, AND THE TEAM LEADER RESPONSIBLE FOR VERIFYING THE CORRECTNESS OF COMPONENTRY FAILED TO DO SO. BOTH INSTANCES WERE THE RESULT OF ISOLATED EMPLOYEE ERRORS. CORRECTIVE ACTION: THE EMPLOYEE AND TEAM LEADER WERE GIVEN CONFIDENTIAL DISCIPLINARY ACTIONS THAT WILL BE MAINTAINED IN THEIR PERSONNEL FILES. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED REPORTING THAT AN ENT PACK (PART NUMBER 89-7324) CONTAINED NON-RFID GAUZE INSTEAD OF RFID GAUZE. THE QUALITY CONTROL SUPERVISOR REVIEWED THE BOM AND DEVICE HISTORY RECORD FOR THE FINISHED GOOD. NO DISCREPANCIES WERE IDENTIFIED. THE DEFECTIVE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE BILL OF MATERIALS AND WORK ORDER FOR THE REPORTED LOT NUMBER CONTAIN RAW MATERIAL NUMBER 901431, WHICH IS AN RFID GAUZE. THE BIN LOCATION FOR THIS ITEM IS M7F1A. THERE IS A SIMILAR GAUZE LOCATED IN BIN M7C1A. PREVENTIVE ACTION: NO PREVENTIVE ACTION HAS BEEN TAKEN. GIVEN THE ISOLATED NATURE OF THIS COMPLAINT, NO POTENTIAL ERRORS WERE IDENTIFIED. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PACK CONTAINED NON-RFID GAUZE INSTEAD OF RFID GAUZE IN THE PACK. THE ERROR WAS DETECTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371257 ENT PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 42012579

    Patients

    Seq Age Sex Outcome Treatment
    1