BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HVT ISIS ENDOTRACHEAL CUFF TUBE

    MDR report key: 2171427 · Received June 29, 2011

    Report

    Report Number
    3003898360-2011-00295
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE PURPLE PORT FOR SUBGLOTTIC SUCTIONING CAME OFF WHILE THE PT WAS INTUBATED WITH THE TUBE. THE MEDICAL ATTENDANT COVERED THE HOLE WITH TAPE AND THE PT REMAINED INTUBATED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HVT ISIS ENDOTRACHEAL CUFF TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK