BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER

    MDR report key: 2992819 · Received February 27, 2013

    Report

    Report Number
    1820334-2013-00109
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    UPON REMOVAL OF THE PIGTAIL CATHETER THE TIP OF THE CATHETER BROKE OFF. IT WAS REMOVED USING AN AMPLATZ GOOSE NECK SNARE KIT. NO PART OF THE DEVICE REMAINED INSIDE THE PT. NO ADVERSE EFFECTS TO THE PT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83587 BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 3544005

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention