BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON PREFORMED UNCUFFED ORAL ET TUBE 4.5 MM

    MDR report key: 1638509 · Received March 22, 2010

    Report

    Report Number
    3003898360-2010-00128
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 1, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BUT NOT RECEIVED YET. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE MARKINGS ON THE ET TUBE ARE TOO FAR UP ON THE TUBE. THIS ISSUE WAS APPARENT DURING INTUBATION. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON PREFORMED UNCUFFED ORAL ET TUBE 4.5 MM UNCUFFED ORAL ET TUBE BTR TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1