BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 5199219 · Received November 3, 2015

    Report

    Report Number
    2936999-2015-00916
    Event Type
    Injury
    Date Received
    November 3, 2015
    Report Date
    October 14, 2015
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K945513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PEDIATRIC TRACHEOSTOMY TUBE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT ALL THE COMPONENTS WERE ASSEMBLED PROPERLY IN THE TUBE. THE LENGTH OF THE CANNULA AND THE ANGLE OF THE TUBE WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE CUSTOMER REPORTED MALFUNCTION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, A TRACHEOSTOMY TUBE HAD TO BE REPLACED. A NURSE PERFORMED A DEVICE REPLACEMENT FOR A PATIENT AT THEIR HOME. WITHIN 10 MINUTES, THE PATIENT'S OXYGEN SATURATION BEGAN TO DROP, THE HEART RATE BEGAN TO INCREASE, AND THE PATIENT'S SKIN COLOR BEGAN TO CHANGE. THE PRIMARY CARE GIVER (PCG) SUCTIONED THE PATIENT AND PERFORMED CHEST PHYSIOTHERAPY, WHICH BROUGHT NO CHANGE TO PATIENT STATUS. THE PCG CALLED 911, AND BEGAN TO MANUALLY VENTILATE THE PATIENT, WHICH WAS CONTINUED UNTIL ARRIVING TO THE HOSPITAL. THE TRACHEOSTOMY TUBE WAS THEN REPLACED BY A PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729513 SHILEY TRACHEOSTOMY TUBES JOH COVIDIEN 4.0 PED 15C0462JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention