BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER MEDICAL ENDO TRACHEAL TUBE

    MDR report key: 14085303 · Received April 11, 2022

    Report

    Report Number
    MW5108919
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 7, 2022
    Manufacturer
    UNK
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE TRYING TO EXTUBATE THE PT POST CABG, THERE WAS NO CUFF LEAK, SO THEY COULD NOT EXTUBATE. WHEN THEY WERE ABLE TO EXTUBATE IT WAS NOTICED THAT THE OUTSIDE CUFF WAS FULLY DEFLATED BUT THE BULB WAS STILL HALF INFLATED, CAUSING A DELAY IN EXTUBATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901564 PARKER MEDICAL ENDO TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNK 2108HV1668M

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention