BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERIDAN NASAL TUBE

    MDR report key: 11951 · Received January 31, 1994

    Report

    Report Number
    11951
    Event Type
    Injury
    Date Received
    January 31, 1994
    Date of Event
    September 29, 1993
    Report Date
    January 31, 1994
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NASAL TUBE WAS USED ON A PT. THE BULB/CUFF BECAME FULL OF HOLES AND LEAKED, CAUSING THE PROCEDURE TO BE DELAYED. IT WAS NECESSARY TO TURN THE PT AND REMOVE THE TUBE AND INSERT ANOTHER TUBE. THERE WAS NO APPARENT INJURY TO THE PT. THE TUBE WAS CLEANSED AND MARKED "CONTAMINATED" AND RETURNED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN NASAL TUBE NASAL TUBE CAT SHERIDAN CATHETER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention