BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    450 SAL EJECTOR 3283

    MDR report key: 5745001 · Received June 23, 2016

    Report

    Report Number
    9612030-2016-00291
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Report Date
    June 2, 2016
    Manufacturer
    COVIDIEN
    Product Code
    DYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 06/23/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. MANUFACTURING RECORDS ARE ROUTINELY REVIEWED PRIOR TO THE RELEASE OF PRODUCT TO ENSURE PROCESS AND PRODUCT COMPLIANCE. NO SAMPLES WERE RECEIVED BY COVIDIEN FOR EVALUATION. BECAUSE SAMPLES WERE NOT AVAILABLE FOR EVALUATION, THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. DUE TO THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION THE FAILURE MODE REPORTED COULD NOT BE CONFIRMED THEREFORE THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER IN PREVIOUS EVALUATIONS WITH THE SAME FAILURE MODE ROOT CAUSE COULD BE GUN WEAR ON DISPENSER THAT OCCASIONED NO ADHESIVE IN SALIVA EJECTOR TIP. CORRECTIVE ACTION ACTUALLY IN THE MACHINE EXTRUDER # (B)(4) PERFORMS THE 100% AUTOMATED ASSEMBLY OF THE BLUE TIP. BEGINS ON (B)(6) 2010, 100 % AUTOMATED PULL TEST MACHINE WAS SET UP IN PERFORMING THE PULL TEST (2.0 LBS.) AS A MINIMUM OPERATION ON ALL ASSEMBLED SALIVA EJECTORS RE-ADJUSTMENT OF SOLVENT APPLICATOR AIRLINE THAT HELPS MAINTAINS CONSISTENCY ON THE SOLVENT APPLICATION PROCESS. THE ABOVE MENTIONED ACTIONS WERE IMPLEMENTED ON THE DATES AS WRITTEN, WITHOUT A LOT NUMBER IT CANNOT BE DETERMINED IF THE SPECIFIC DEVICE THAT FAILED PER THIS CUSTOMER COMPLAINT WAS MANUFACTURED PRIOR OR AFTER THE ACTIONS ABOVE LISTED. THE MAINTENANCE OF THE GAIN KIT DISPENSER WAS INCLUDED IN MAXIMO SYSTEM TO PERFORM PERIODICALLY MAINTENANCE. 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) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER REPORTS THAT DEVICE DOES NOT FIT THEIR SCOPE. THE BLUE CAP PIECE FALLING OFF IN PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400939 450 SAL EJECTOR 3283 SALIVA EJECTOR DYN COVIDIEN 8881450004

    Patients

    Seq Age Sex Outcome Treatment
    1