BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON ET TUBE UNCUFFED 2.5MM PEDIATRIC

    MDR report key: 1591053 · Received January 25, 2010

    Report

    Report Number
    3003898360-2010-00029
    Event Type
    Death
    Date Received
    January 25, 2010
    Date of Event
    December 25, 2009
    Report Date
    January 6, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WILL BE NO SAMPLE RETURNED TO EVALUATE. THE SAMPLE IS BEING RETAINED BY RISK MANAGEMENT AT THE FACILITY. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: NEWBORN PREMATURE INFANT WAS INTUBATED IN ORDER TO RECEIVE SURFACTANT THROUGH THE ET TUBE. THE INFANT'S OXYGEN SATURATION DROPPED AND NECK AND ABDOMEN BECAME DISTENDED WITH FREE AIR. PT WENT INTO CARDIO-PULMONARY ARREST. RESUSCITATION WAS ATTEMPTED BUT PT EXPIRED. CLINICIAN WHO REPORTED EVENT BELIEVES THERE IS THE POSSIBILITY THAT THE TIP OF THE ET TUBE IS SHARP ENOUGH TO CAUSE A TRACHEAL TEAR. THE CLINICIAN REPORTED THAT THE AUTOPSY RESULTS ALLEGEDLY REVEALED A TRACHEAL TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ET TUBE UNCUFFED 2.5MM PEDIATRIC PEDIATRIC ET TUBE BTR TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death