BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3611 LITE GLOVE

    MDR report key: 4213564 · Received October 30, 2014

    Report

    Report Number
    9612030-2014-00065
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/30/2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS MANUFACTURED ON 04/23/2014. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE ISSUE DESCRIBED BY THE CUSTOMER. 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 4162104864X WAS RECEIVED FOR EVALUATION. AFTER PERFORMING VISUAL INSPECTION PER PROCEDURE, THE REPORTED CONDITION WAS CONFIRMED. THIS FAILURE MODE COULD OCCUR DURING THE FORMING PROCESS DUE TO INCORRECT LITE GLOVE FORMING. AS CONTAINMENT ACTIONS, DURING THE MANUFACTURING PROCESS A FUNCTIONAL TEST IS PERFORMED WITH VISUAL AID. AWARENESS TRAINING WAS PERFORMED FOR ALL PERSONNEL TO ENSURE THEY ARE AWARE ABOUT THIS REPORTED CONDITION, AND TO ENHANCE THIS TYPE OF ISSUE DURING THE VISUAL INSPECTION PROCESS. THE PROCESS WILL BE UPDATED TO REFLECT THE FAILURE MODE REPORTED AND THE REACTION PLAN TO MITIGATE THE ISSUE REPORTED. THE SAMPLE BOARD WAS MADE TO BRING FOCUS TO THE FAILURE MODE IN PRODUCTION AND IMPROVE THE DETECTION PROCESS. A QUALITY ALERT HAS BEEN POSTED IN THE PRODUCTION LINE TO BRING AWARENESS AND NOTIFY THOSE EMPLOYEES INVOLVED IN THE PROCESS ABOUT THE REPORTED CONDITION. THE FOLLOWING ACTIVITIES HAD BEEN COMPLETED AS PREVENTIVE ACTIONS; THE REPLACEMENT OF TWO CERAMIC LAMPS, AN ADJUSTMENT IN THE ALIGNMENT, AND SHARPENING OF THE KNIVES. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT AFTER A COUPLES OF MINUTES OF USE, THE USER NOTICED SEVERAL CUTTINGS ON THE DEVICE. THE USER'S GLOVES WERE CHANGED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CUSTOMER FURTHER REPORTS THAT THERE WAS NO HARM TO THE PATIENT AND THAT ANTIBIOTICS WERE PRESCRIBED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695632 3611 LITE GLOVE LITE GLOVE FMC COVIDIEN 31140208 4105103764X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other