BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 2992176 · Received February 28, 2013

    Report

    Report Number
    2936999-2013-00132
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    September 4, 2012
    Report Date
    February 1, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Removal / Correction Number
    Z-2174-2012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE AVAILABLE FOR ANALYSIS HOWEVER, RECALL Z-2174-2012 WAS INITIATED FOR MODELS SHILEY 8LPC AND 8FEN THAT HAVE HAD VOLUME LEAKAGE AND/OR DISCONNECTION BETWEEN THE INNER AND OUTER CANNULAE. ADDITIONALLY, A CORRECTIVE AND PREVENTATIVE ACTION WAS INITIATED TO DOCUMENT THE INVESTIGATION EFFORTS RELATED TO THE ROOT CAUSE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE REPORTING STATED THAT THE INTERNAL CANNULA DID NOT CONNECTED ANYMORE WITH THE EXTERNAL CANNULA. THE REPORTER STATED DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85917 SHILEY LOW PRESSURE CUFFED TRACH TUBE JOH COVIDIEN, FORMERLY TYCO HEALTHCARE 110800421X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention