BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 1821488 · Received August 25, 2010

    Report

    Report Number
    2936999-2010-01132
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEATLHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Removal / Correction Number
    Z-1464-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. THE LOT NUMBER REPORTED IS INCLUDED IN THE ABOVE REFERENCED ACTION.

    Description of Event or Problem · 1

    CALLER REPORTED THE PILOT BALLOON ON THE TRACHEOSTOMY TUBE FAILED AFTER 3 DAYS OF BEING IN THE PT AND SHE HAD TO REPLACE IT. HE HAD TO BE REINTUBATED. SHE SAYS THAT SHE DID NOT SAVE THE TRACH AND IT HAS BEEN THROWN OUT AND NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN, FORMERLY TYCO HEATLHCARE 090200177

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention