BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2100805 · Received May 19, 2011

    Report

    Report Number
    2936999-2011-00337
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE THE DATE OF MFR CANNOT BE DETERMINED. THE TUBE WAS DISCARDED THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE OR THE LOT NUMBER.

    Description of Event or Problem · 1

    THE CALLER STATED THAT A NURSE WAS CLEANING A TRACHEOSTOMY TUBE AND IT CRACKED ON BOTH SIDES. THE INTENSIVIST ON DUTY WAS ALERTED AND HE CHANGED THE TUBE FOR A NEW ONE. ACCORDING TO THE CALLER THIS OCCURRED SOMETIME IN THE LAST YEAR (HOWEVER, THEY WERE ONLY REPORTING IT JUST NOW). THE TUBE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. THERE ARE NO SPECIFIC PT DETAILS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention