BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PEDIATRIC CUFFED LONG

    MDR report key: 1962638 · Received January 12, 2011

    Report

    Report Number
    2936999-2011-00020
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 13, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 3-5 DAYS OF USE, AIR LEAKED FROM THE CUFF OF THE TRACHEOSTOMY TUBE. THE DATE OF INITIAL PLACEMENT OF THE TUBE IS NOT KNOWN. THE PATIENT REQUIRED A NON-ROUTINE REMOVAL AND RE CANNULATION OF THE TUBE. THE PACKAGING WAS DISCARDED AND THE LOT NUMBER OF THE TUBE IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention