BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2852478 · Received November 15, 2012

    Report

    Report Number
    2852478
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    THE RADIAL ARTERY CATHETER DID NOT THREAD CORRECTLY RESULTING IN INABILITY TO SECURE ADEQUATE PATIENT PLACEMENT. THE CATHETER APPEARED KINKED UPON WITHDRAWAL.THERE WAS NO PATIENT HARM. THIS ONLY OCCURED ONCE. THE PLAN OF CARE FOR THE PATIENT DID NOT CHANGE. THE PATIENT HAD SURGERY AND WAS RELEASED TO HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * WIRE, GUIDE, CATHETER DQX ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC * CF2067235

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other| R NO OTHER THERAPIES