BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOX SVO2 PA CATHETER, 8FR

    MDR report key: 5993318 · Received October 3, 2016

    Report

    Report Number
    2025816-2016-00157
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 6, 2016
    Report Date
    October 3, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    PMA / PMN Number
    K820674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# REVIEW: A REVIEW OF LOT# 3253340 SHOWED THAT (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED IN JUNE 2016, CITING NO ANOMALIES. NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING TWO 50328-07, TRIOX SVO2 PA CATHETER, 8FR, LOT# 3253340 (MFD. 06/2016). REPORT STATES; WHILE INSERTION OF THE CATHETER, THERE SEEMED TO BE A KINK NEAR THE THERMISTOR THAT OCCURRED. THE DOCTOR WAS UNABLE TO PULL THE CATHETER BACK THROUGH THE CORDIS AND THEY HAD TO SURGICALLY REMOVE THE CATHETER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645982 TRIOX SVO2 PA CATHETER, 8FR TRIOX SVO2 PA CATHETER, 8FR DQE ICU MEDICAL, INC. 50328-07 3253340

    Patients

    Seq Age Sex Outcome Treatment
    1