BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVIN TUBE

    MDR report key: 87313 · Received April 29, 1997

    Report

    Report Number
    MW1011229
    Event Type
    Malfunction
    Date Received
    April 29, 1997
    Date of Event
    February 19, 1997
    Report Date
    April 17, 1997
    Manufacturer
    SEAMLESS/DIV OF PROFESSIONAL MED PRD
    Product Code
    FRQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT ENTERED THE EMERGENCY ROOM WITH SEVERE STOMACH PAINS, MD REQUESTED NG STOMACH TUBE BE INSERTED INTO PT, WHEN THE NURSE WENT TO CONFIRM PLACEMENT SHE REALIZED THE TUBE WAS DEFECTIVE. THE HOLES WERE IN THE WRONG END. NURSE REMOVED DEFECTIVE TUBE AND INSERTED NEW TUBE WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVIN TUBE STOMACH TUBE 12 FR FRQ SEAMLESS/DIV OF PROFESSIONAL MED PRD 15-5710 +H44215571012*

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other