BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP PACK

    MDR report key: 5793982 · Received July 14, 2016

    Report

    Report Number
    3005011024-2016-00015
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 14, 2016
    Report Date
    July 14, 2016
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THIS HAS BEEN DETERMINED TO BE A RANDOM EVENT DUE TO EMPLOYEE INATTENTIVENESS DURING MANUFACTURING. INK PENS ARE USED NEAR THE MANUFACTURING AREA FOR COMPLETION OF WORK ORDER DOCUMENTATION. CORRECTIVE ACTION: THE MANUFACTURING EMPLOYEE RESPONSIBLE FOR THE OVERSIGHT HAS RECEIVED CONFIDENTIAL ACTION THAT HAS BEEN DOCUMENTED IN THE EMPLOYEE'S FILE. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THAT A HIP PACK (FINISHED GOOD 89-4508, LOT NUMBER 42239360) CONTAINED AN INK PEN INSIDE OF THE PACK. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE FOUND; HOWEVER, IT WAS IDENTIFIED THAT ONE EMPLOYEE WAS LISTED FOR THE COMPLETE MANUFACTURING PROCESS. INK PENS ARE USED NEAR THE MANUFACTURING AREA FOR COMPLETION OF WORK ORDER DOCUMENTATION. PREVENTIVE ACTION: DUE TO THE INVESTIGATION AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. 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 STAFF SET UP THE ROOM FOR A TOTAL HIP PROCEDURE AND WERE MOVING THE PATIENT INTO THE ROOM. AT THIS TIME, AN O.R STAFF MEMBER TOOK THE LAST LAYER OF THE CUSTOMER TRAY BUNDLE APART AND FOUND AN INK PEN LYING ON THE MAYO TRAY/PLATFORM TRAY OF THE CUSTOM TRAY PRODUCT. THE ROOM WAS BROKEN DOWN AND SET BACK UP. THE TIME DELAY WAS APPROXIMATELY 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448241 HIP PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 42239360

    Patients

    Seq Age Sex Outcome Treatment
    1