BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1936041 · Received December 13, 2010

    Report

    Report Number
    2936999-2010-01371
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK AND THEREFORE THE DATE OF MANUFACTURE CANNOT BE DETERMINED. THE TUBE WAS DISCARDED AND THEREFORE UNAVAILABLE FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE PT HAD A 6DCT TRACHEOSTOMY TUBE WITH A HOLE IN IT AND THE PT WAS RECANNULATED. THE CALLER STATED THAT AND THE PT HAD THROWN AWAY THE TUBE. THE CALLER DID NOT PROVIDE A LOT NUMBER FOR THE TUBE, DID NOT KNOW THE AREA OF THE HOLE OR LEAK, AND DID NOT WANT TO PROVIDE ANY ADDITIONAL FAILURE INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention