BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCLE C SILICONE CATHETER KIT

    MDR report key: 286051 · Received July 14, 2000

    Report

    Report Number
    1056436-2000-00144
    Event Type
    Malfunction
    Date Received
    July 14, 2000
    Report Date
    June 16, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 6/16/00, THE FACILITY'S LEAD RADIOLOGY TECHOLOGIST INFORMED THE MFR'S (MFR.) SENIOR ACCOUNT MGR OF THE FOLLOWING: WHILE FLUSHING THE CATHETER AND IMPLANTATION, THE FLUSHING SOLUTION LEAKED OUT OF THE CATHETER EXTENSION LEG. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCLE C SILICONE CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other