BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HVT ET TUBE 7.0 MM

    MDR report key: 2241695 · Received August 19, 2011

    Report

    Report Number
    3003898360-2011-00360
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO PRODUCT SAMPLE FOR INVESTIGATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE CENTIMETER MARKINGS ARE COMING OFF THE TUBE AFTER THE PT HAS BEEN INTUBATED FOR 3-4 DAYS. COMPLAINT ALLEGES THAT THE HOSPITAL HAD 2 CASES OF SELF-EXTUBATION DUE TO GRADUAL DISLODGEMENT THAT WENT UNNOTICED BECAUSE OF THE MARKINGS BEING GONE. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HVT ET TUBE 7.0 MM HVT ET TUBE BTR TELEFLEX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1