BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-VENTED WIT BULBOUS TIP

    MDR report key: 4102768 · Received September 12, 2014

    Report

    Report Number
    9612030-2014-00053
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    August 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORD WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE PRODUCTION OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. TWO SAMPLES WERE PROVIDED BY THE CUSTOMER AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. VISUAL INSPECTION, CONFIRMED AN ACCEPTABLE CONDITION. DIMENSIONAL INSPECTION WAS IN ACCORDANCE TO PROCEDURE AND FUNCTIONAL TESTS WERE CONDUCTED TO CONFIRM THAT THE DEVICE WAS WITHIN AN ACCEPTABLE CONDITION. AFTER REVIEWING PARTS INVOLVED, A WALK THROUGH OF THE PROCESS AREA WAS CONDUCTED BY THE CROSS FUNCTIONAL MOLDING TEAM. A POTENTIAL ROOT CAUSE IDENTIFIED WAS DUE TO INITIAL STATEMENT REPORTED FROM THE CUSTOMER, THE PATIENT CODED ABOUT AN HOUR AFTER EATING LUNCH AND THE YANKAUER CLOGGED DUE TO SUCTIONING LARGER PIECES OF FOOD, INCLUDING LETTUCE. BASED ON THE INFORMATION AVAILABLE AND INVESTIGATION OF THE CONDITION REPORTED, A CORRECTIVE ACTION IS NOT DEEMED NECESSARY AT THIS TIME. APPROPRIATE MANUFACTURING AND QUALITY ASSURANCE PERSONNEL HAVE BEEN MADE AWARE OF THIS COMPLAINT IN AN EFFORT TO FOCUS ATTENTION ON THIS ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL ALSO BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A YANKAUER. THE CUSTOMER REPORTS THAT A PATIENTS STOMACH CONTENTS WERE ASPIRATED AND DURING SUCTION, THE HANDLE CONTINUED TO CLOG/FAIL. THE CUSTOMER STATED THAT THEY FELT IT DID NOT HAVE SUFFICIENT SUCTION AS A RESULT OF THE SIZE AND CLOG RESISTANCE. ULTIMATELY, THEY USED A STRAIGHT TUBE, AND THE PATIENT EXPIRED. THIS EVENT OCCURRED AT THE PATIENTS BEDSIDE IN THE PATIENTS ROOM. THE PATIENT CODED ABOUT AN HOUR AFTER EATING LUNCH. THE PATIENT WAS BEING SUCTIONED AND THE YANKAUER CLOGGED DUE TO SUCTIONING LARGER PIECES OF FOOD, INCLUDING LETTUCE. THE CUSTOMER FURTHER STATED THAT THEY CHECKED THE TUBING AND THE SUCTION FROM THE WALL AND IT LOOKED GOOD. THEY DID CHANGE OUT THE YANKAUER TO A STRAIGHT TUBE. THE CUSTOMER REPORTS THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566379 NON-VENTED WIT BULBOUS TIP YANKAUER JOL COVIDIEN K86 403424264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other