BEUDAMED
    FDA Adverse Event Other Summary report: N

    OTN INTRODUCER

    MDR report key: 1925508 · Received December 10, 2010

    Report

    Report Number
    2925153-2010-00017
    Event Type
    Other
    Date Received
    December 10, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    NEO MEDICAL INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER: BREAKAWAY WING BROKE OFF ON ONE SIDE. WAS ABLE TO REPLACE THE CATHETER WITHOUT ANOTHER VENIPUNCTURE USING OUR CURRENT BREAKAWAY INTRODUCER. PATIENT WAS NOT INJURED OR HARMED, NO INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTN INTRODUCER PEELABLE SHEATH INTRODUCER LJS NEO MEDICAL INC 2076-30 1002

    Patients

    Seq Age Sex Outcome Treatment
    1