BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/HVT ENDOTRACHEAL TUBE, 7.5

    MDR report key: 2142093 · Received May 24, 2011

    Report

    Report Number
    3003898360-2011-00246
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 11, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON ON THE ET TUBE LEAKED DURING INTUBATION. THE PT HAD TO BE RE-INTUBATED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERIDAN/HVT ENDOTRACHEAL TUBE, 7.5 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK