BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER FLEX TIP ETT

    MDR report key: 272909 · Received April 6, 2000

    Report

    Report Number
    MW1018607
    Event Type
    Injury
    Date Received
    April 6, 2000
    Date of Event
    April 5, 2000
    Report Date
    April 6, 2000
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PT INTUBATED WITH SIZE 8.0 PARKER FLEX-TIP ENDOTRACHEAL TUBE PRIOR TO FIBEROPTIC BRONCHOSCOPY. PT INTUBATED EASILY UNDER DIRECT LARYNGOSCOPY. DURING BRONCHOSCOPY, ABLE TO EASILY ADVANCE PENTAX 15X BRONCHOSCOPE THROUGH ENDOTRACHEAL TUBE, BUT EXTREME DIFFICULTY IN WITHDRAWING BRONCHOSCOPE FROM ENDOTRACHEAL TUBE, REQUIRING SIGNIFICANT EXERTION, DESPITE ADEQUATE LUBRICATION WITH SURGILUBE. NEXT DAY PT DEVELOPED HIGH PEAK AIRWAY PRESSURE. UNABLE TO ADVANCE SUCTION CATHETER THROUGH ENDOTRACHEAL TUBE. PT WITH SIGNIFICANT HYPOXEMIA. PT'S ENDOTRACHEAL TUBE CHANGED AND ENDOTRACHEAL TUBE FOUND TO HAVE SIGNIFICANT MUCUS PLUGGING DUE TO EXTENDED FLEX-TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARKER FLEX TIP ETT ENDOTRACHEAL TUBE SIZE 8.0 BTR PARKER MEDICAL H-80 2000-C-16E

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening