BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURACATH

    MDR report key: 8508593 · Received April 12, 2019

    Report

    Report Number
    8508593
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 28, 2019
    Report Date
    March 28, 2019
    Manufacturer
    INTERRAD MEDICAL, INC
    Product Code
    OKC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTING A DOUBLE LUMEN CENTRAL VENOUS LINE, MD APPLIED 7 FR SECURE-A-CATH AND NOTED THAT THE LINES WERE OCCLUDED FOLLOWING APPLICATION OF THE DEVICE. DEVICE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302444 SECURACATH IMPLANTED SUBCUTANEOUS SECUREMENT CATHETER OKC INTERRAD MEDICAL, INC 7F A1850

    Patients

    Seq Age Sex Outcome Treatment
    1