BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7487-ECL MINI PLUS KIT

    MDR report key: 5148603 · Received October 14, 2015

    Report

    Report Number
    9612030-2015-00098
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Report Date
    October 5, 2015
    Manufacturer
    COVIDIEN
    Product Code
    FMC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/19/2016. THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. A DECONTAMINATED SAMPLE WITH LOT NUMBER 5217106664X WAS RECEIVED AND WAS VISUALLY INSPECTED ACCORDING TO PROCEDURE AND THE REPORTED CONDITION WAS NOT CONFIRMED, INSTEAD STRESS MARKS WERE FOUND, WITHOUT A SPLIT IN THE WALL OF THE HANDLE SECTION. THE INVESTIGATION DETERMINED THAT THIS IS CAUSED BY DIMENSIONAL TOLERANCE THAT CAN LEAD TO DIFFICULTY INSERTING THE LIGHT GLOVE ONTO THE LIGHT HANDLE BY THE USER. THE DIMENSIONAL TOLERANCE IS RELATED TO A SLIGHT REDUCTION OF THE INSIDE DIAMETER OF THE LIGHT GLOVE HANDLE COVER. THIS REDUCTION IN DIAMETER WAS ONE OF THE ACTIONS IMPLEMENTED TO ELIMINATE PLEATS IN THE GLOVE AND MINIMIZE THE POTENTIAL FOR SPLITS AND TEARS. THIS REDUCTION IN DIAMETER WAS OBSERVED IN A SMALL NUMBER OF GLOVES, AND IF IT OCCURS, IT CAN LEAD TO LIGHT GLOVES THAT FIT TIGHTLY OVER THE LIGHT HANDLE. IF FORCED ONTO THE HANDLE BY THE USER, THE GLOVE MAY TEAR OR SPLIT WHEN BEING APPLIED. A PRODUCTION NOTIFICATION WAS PERFORMED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE OF THE REPORTED CONDITION. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED EVENT. WHEN ROOT CAUSE(S) IS DETERMINED THE APPROPRIATE ACTIONS WILL BE TAKEN TO ADDRESS THE REPORTED CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER STATES THE LIGHT GLOVE SPLIT WHILE APPLYING TO LIGHT HANDLE (COVIDIEN HANDLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680623 7487-ECL MINI PLUS KIT LITE GLOVE FMC COVIDIEN 573375A 5217106664X

    Patients

    Seq Age Sex Outcome Treatment
    1