BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRAL VENOUS CATHETER KIT

    MDR report key: 275207 · Received April 25, 2000

    Report

    Report Number
    1056436-2000-00078
    Event Type
    Other
    Date Received
    April 25, 2000
    Date of Event
    March 30, 2000
    Report Date
    March 30, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 03/30/2000, THE FACILITY'S MATERIALS MANAGER INFORMED THE MANUFACTURER'S (MFR) REPRESENTATIVE OF THE FOLLOWING: THE DEVICE WAS OPENED FOR THE PROCEDURE AND THE PHYSICIAN NOTED THAT THE CATHETER (WHITE PART) HAD A BLACK RESIDUE ON IT. THE PHYSICIAN WAS CONCERNED ABOUT POSSIBLE INFECTION, SO THE DEVICE WAS NOT USED. ANOTHER DEVICE SAME CATALOG/LOT NUMBER WAS USED WITHOUT FURTHER INCIDENT. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE IN QUESTION IS EXPECTED TO BE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL VENOUS CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA SE99392

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other