BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2864325 · Received December 5, 2012

    Report

    Report Number
    2936999-2012-00638
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    CALLER STATES, THE CUFF IS NOT HOLDING AIR. THE CALLER CONFIRMED THAT TUBE IS CHANGED EVERY 3 MONTHS AS PART OF ROUTINE REPLACEMENT WHICH EXCEEDS THE RECOMMENDED 29 DAYS OF USE AS INDICATED IN THE DIRECTIONS FOR USE. NEW INFORMATION PROVIDED ON (B)(4) 2012 INDICATED THAT THE TUBE WAS REPLACED SO THAT IT COULD BE RETURNED BUT NORMAL PRACTICE IS THAT THEY USE FOR 3 MONTHS AND CHANGE INNER CANNULA 2 TIMES A DAY. THE CALLER CONFIRMED THE EXTUBATION AND RECANNULATION OF A REPLACEMENT TUBE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA FENESTRATED LOW JOH COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention