BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED

    MDR report key: 1920056 · Received December 2, 2010

    Report

    Report Number
    2936999-2010-01305
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 4, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE SAMPLE IS RETURNED A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COVIDIEN REPRESENTATIVE IN (B)(4) RECEIVED A REPORT THAT THE CUSTOMER STATED THE CANNULA COULD NOT BE INSERTED IN THE PT DURING A TRACHEOSTOMY AS THE TIP OF THE CANNULA WAS NOT SMOOTH. IT WAS REPORTED THERE WAS DESATURATION OF THE PT AND THE TUBE WAS REMOVED AND THE PT WAS RE-CANNULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1006002401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention