BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY CUFFED PEDIATRIC

    MDR report key: 1962653 · Received January 12, 2011

    Report

    Report Number
    2936999-2011-00027
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 15, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK AND THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. IF THE SAMPLE IS RETURNED A FAILURE INVESTIGATION WILL BE PERFORMED. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER 11 DAYS OF USE, AIR LEAKED. THEY FOUND A PINHOLE IN PILOT BALLOON. THE PT REQUIRED A NON-ROUTINE RE-CANNULATION. NO PT HARM WAS REPORTED. A PRE-TEST OF THE TUBE WAS DONE. THE TUBE'S LOT NUMBER IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention