BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER MEDICAL TRACH VAC ET TUBE

    MDR report key: 5746371 · Received June 23, 2016

    Report

    Report Number
    1724737-2016-00002
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 22, 2016
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    K110269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE BEING EVALUATED FOR ROOT CAUSE.

    Description of Event or Problem · 1

    DURING A BRONCHOSCOPY TO REMOVE SECRETIONS, ON APPROXIMATELY THE 3RD REMOVAL OF THE BRONCHOSCOPE FROM THE ET TUBE, IT BECAME STUCK. DR. (B)(6) PULLED HARD AND ATTEMPTED TO ROTATE THE BRONCHOSCOPE, BUT COULD NOT REMOVE THE BRONCHOSCOPE FROM THE ET TUBE. DR. (B)(6) REMOVED THE BRONCHOSCOPE WITH THE ET TUBE TOGETHER DURING EXTUBATION. THE PATIENT WAS INTUBATED WITH ANOTHER PRODUCT AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS NOT INJURED, BUT THE PHYSICIAN FELT A POTENTIAL INJURY COULD HAVE OCCURRED WITHOUT THE ACTIONS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401536 PARKER MEDICAL TRACH VAC ET TUBE SUBGLOTTIC SUCTIONING EVAC TUBE BTR PARKER MEDICAL H-PFTVPU-75

    Patients

    Seq Age Sex Outcome Treatment
    1