BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1880269 · Received October 19, 2010

    Report

    Report Number
    2936999-2010-01268
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962172
    Removal / Correction Number
    Z-1463-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE LOT NUMBER PROVIDED IN THE REPORTED EVENT WAS NOT THE LOT NUMBER OF TUBE THAT WAS REC'D FOR INVESTIGATION. ONE 6 DCT WITH LOT 0906001603 WAS REC'D AND INVESTIGATION CONFIRMED A LEAK IN THE PILOT BALLOON SEAM. (B)(4).

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE TUBES CUFF WOULD NOT INFLATE. THE PT HAD TO BE REINTUBATED WITH A DIFFERENT TUBE WHICH WORKED. THE CALLER WOULD NOT PROVIDE THE CUSTOMERS CONTACT INFO BUT DID REPORT THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/ FORMERLY TYCO HEALTHCARE 100600239

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention