BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 737973 · Received July 20, 2006

    Report

    Report Number
    2936999-2006-00688
    Event Type
    Injury
    Date Received
    July 20, 2006
    Date of Event
    January 1, 2006
    Report Date
    July 14, 2006
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT IS CURRENTLY IN PROGRESS. THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2006, NELLCOR PURITAN BENNETT RECEIVED A REPORT OF PILOT LINE SEPARATION FROM A SCT SPECIALIZED TRACHEOSTOMY TUBE. THE CALLER REPORTED AFTER ONE WEEK OF USE, THE PILOT LINE SEPARATED FROM THE TRACHEOSTOMY TUBE. THE CALLER REPORTED NO UNUSUAL STRAIN WAS EXERTED ON THE PILOT LINE. THE CALLER REPORTED THAT REPLACEMENT OF THE TUBE WAS REQUIRED. THE CALLER REPORTED HAVING A TOTAL OF 4 OCCURRENCES OF THE SAME REPORT. THE CALLER INDICATED THAT ONE SAMPLE WAS AVAILABLE FOR EVALUATION, BUT THAT THE OTHERS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SPECIALIZED TRACHEOSTOMY TUBE BTO JUAREZ HENEQUEN SCT *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN