BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE

    MDR report key: 2003616 · Received February 23, 2011

    Report

    Report Number
    2936999-2011-00076
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER PROVIDED IS INVALID OR INCOMPLETE AND THEREFORE THE DATE OF MFR CANNOT BE DETERMINED. A FAILURE INVESTIGATION WILL BE PERFORMED ON THE RETURNED TUBE. IF SIGNIFICANT INFO 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 CALLER REPORTED THAT THEY HAD A PT IN THE ICU THAT EXPERIENCED A CARDIAC ARREST. THE PT HAD SURGERY FOR PLACEMENT OF A TRACHEOSTOMY TUBE A FEW DAYS PRIOR TO THE EVENT. WHILE ATTEMPTING TO RESUSCITATE THE PT, THEY FOUND IT VERY DIFFICULT TO VENTILATE. THE DOCTOR MADE A DECISION TO DECANNULATE THE PT AND TO INTUBATE USING AN ENDOTRACHEAL TUBE. AFTER INTUBATION, THEY WERE ABLE TO VENTILATE THE PT WITHOUT DIFFICULTY. THE TRACHEOSTOMY TUBE WAS EXAMINED AFTER REMOVAL AND FOUND TO HAVE A PROTRUSION OR HERNIATION OF THE CUFF. THE CALLER STATED THAT AS A RESULT OF THIS EVENT, THE PT HAS SUFFERED ANOXIC BRAIN DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE TRACHEOSTOMY TUBE JOH COVIDIEN/FORMERLY TYCO HEALTHCARE 1000001549

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability