BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO

    MDR report key: 1882007 · Received October 18, 2010

    Report

    Report Number
    MW5017886
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 18, 2010
    Manufacturer
    COOK, COVIDIEN
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT UNDERWENT AN UNEVENTFUL PERCUTANEOUS TRACHEOSTOMY TUBE PLACEMENT USING TYCO 8PERC SHILEY THAT IS SUPPLIED IN THE CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SETS AND TRAYS. LESS THAN 24 HOURS LATER, PT BECAME HYPOXIC WITH PERSISTANT CUFF LEAK REQUIRING EMERGENT ENDOTRACHEAL INTUBATION AND REMOVAL OF THE DEFECTIVE TRACHEOSTOMY TUBE AND REPLACEMENT OF THE TUBE WITH A NEW ONE. UPON EXAMINING THE DEFECTIVE TUBE, A DEFECT IN THE CUFF WAS IDENTIFIED. WE RECOGNIZED THAT THERE HAVE BEEN A VOLUNTARY PRODUCT RECALL FOR SOME, BUT NOT ALL MODELS. DATES OF USE: (B)(6) 2010 - 16 HOURS. DIAGNOSIS OR REASON FOR USE: ACUTE RESPIRATORY FAILURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO BLUE RHINO PERCUTANEOUS TRACHEOSTOMY SET BTO COOK, COVIDIEN 2343921

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| S