BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER MEDICAL TRACH VAC ET TUBES

    MDR report key: 5746377 · Received June 23, 2016

    Report

    Report Number
    1724737-2016-00003
    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. DEVICE NOT RETURNED BY CUSTOMER FOR EVALUATION. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    A SHORT TIME AFTER INTUBATION ON 2 DIFFERENT PATIENTS, AS THE TUBE WARMED UP, THE ET TUBES KINKED. THE FIRST PATIENT TUBE KINKED JUST OUTSIDE THE PATIENT'S MOUTH, THE SECOND TUBE WAS REPORTED AS KINKED IN A TWISTING FASHION. THE KINKING IN THE SECOND TUBE OCCURRED JUST INSIDE THE ORAL CAVITY. THE KINK'S CAUSED PRESSURES TO INCREASE WHICH INDICATED IMPROPER FLOW. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401301 PARKER MEDICAL TRACH VAC ET TUBES SUBGLOTTIC SUCTIONING EVAC TUBES BTR PARKER MEDICAL H-PFTVPU-80 1602TVU0226M

    Patients

    Seq Age Sex Outcome Treatment
    1