BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLUNG CATHETER KIT

    MDR report key: 6602696 · Received May 31, 2017

    Report

    Report Number
    3009763347-2017-00004
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    December 29, 2015
    Report Date
    May 31, 2017
    Manufacturer
    ALUNG TECHNOLOGIES, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE SUMMARY OF THE EVENT: BASED ON INFORMATION FROM DR (B)(6) WHO DID THE CATHERIZATION - WHEN THE CATHETER WAS PLACED ON THE PATIENT IT BROKE DURING INSERTION IN THE JUG VEIN LEADING TO A HIGH RISK OF GAS EMBOLISM. THIS REPORT WAS SENT TO (B)(6) AND CLOSED BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384375 HEMOLUNG CATHETER KIT HEMOLUNG CATHETER KIT DQR ALUNG TECHNOLOGIES, INC. REF 30100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other