BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEO-FIT NEONATAL ENDOTRACHEAL TUBE GRIP

    MDR report key: 465542 · Received May 27, 2003

    Report

    Report Number
    465542
    Event Type
    Injury
    Date Received
    May 27, 2003
    Date of Event
    May 9, 2003
    Report Date
    May 20, 2003
    Manufacturer
    ACKRAD LABORATORIES, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOTRACHEAL TUBE BECAME DISLODGED AND PT DESATURATED (PO2 C50). RN ATTEMPTED TO REMOVE ET TUBE AND TUBE HOLDER, BUT FOUND RESISTANCE. ATTEMPTED TO BAG PT OVER TUBE HOLDER BUT UNABLE TO GET SATISFACTORY SEAL. ATTEMPTED TO REMOVE TUBE HOLDER AGAIN WITH NEED TO OVERCOME RESISTANCE. WHEN TUBE HOLDER "LOLLIPOP" WAS REMOVED IT WAS DISCOVERED THAT LARGE PORTION OF EARLOBE WAS ADHERED TO STICKY SURFACE OF "LOLLIPOP". PT WAS STABILIIZED BUT RESULTED IN AVULSION OF EARLOBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO-FIT NEONATAL ENDOTRACHEAL TUBE GRIP ET TUBE HOLDER CBH ACKRAD LABORATORIES, INC. PRODUCT# 42-2540 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Required Intervention