BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 1150063 · Received August 29, 2008

    Report

    Report Number
    2518433-2008-00023
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    June 24, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    k810675
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    INFO REC'D BY MEDWATCH REPORT. IT WAS REPORTED THAT THE SINGLE LUMEN ARTERIAL CATHETER WAS BEING USED ON A FEMALE PT WITH CORONARY HEART DISEASE. THE REPORT STATES THAT PHYSICIAN SUTURED THROUGH THE CATHETER CAUSING IT TO STAY IN PLACE. WHEN THE CATHETER WAS REMOVED, THE TIP BROKE OFF AND WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ARTERIAL CATHETER PRODUCTS DQO ARROW INTL., INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO