BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISIS SUBGLOTTIC ET TUBE 7.5MM

    MDR report key: 1921049 · Received November 11, 2010

    Report

    Report Number
    3003898360-2010-00474
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: AFTER INTUBATION IT WAS OBSERVED, THE SUCTION PORT WAS BROKEN OFF AND FLUID WAS COMING OUT THE HOLE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISIS SUBGLOTTIC ET TUBE 7.5MM SUBGLOTTIC ET TUBE BTR TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA