BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT SOFT PLUS

    MDR report key: 6971133 · Received October 24, 2017

    Report

    Report Number
    6971133
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    August 9, 2017
    Report Date
    October 19, 2017
    Manufacturer
    WESTMED, INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(4) THE SUPPLIER NOTIFIED OF PROBLEM WITH DUAL TUBING ON HIGH FLOW NASAL CANNULAS (NC). UPON FURTHER INSPECTION, ONE LUMEN OF THE TUBING WAS FOUND TO BE BROKEN. PULLED ALL OF THE LOT OF THESE NASAL CANNULAS. LOT # 031717T60 (SIZE NEONATE) AND LOT # 033017T62 ( SIZE INFANT) WHICH WERE AFFECTED AND CURRENTLY WAITING ON RESPONSE FROM THE MANUFACTURER WHO COLLECTED THE DEFECTIVE CANNULAS AND IS RUNNING TEST ON THEM. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750823 COMFORT SOFT PLUS CANNULA, NASAL, OXYGEN CAT WESTMED, INC. 0559 031717T60

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR