BEUDAMED
    FDA Adverse Event Other Summary report: N

    VORTEX WITH KIT

    MDR report key: 299438 · Received October 6, 2000

    Report

    Report Number
    1056436-2000-00201
    Event Type
    Other
    Date Received
    October 6, 2000
    Date of Event
    September 6, 2000
    Report Date
    September 7, 2000
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY'S BUYER INFORMED THE MANUFACTURER'S (MFR) CUSTOMER SERVICE REP OF THE FOLLOWING: OPENED KIT BOX AND SHEATH WAS NOTED SPLIT. THE MFR'S REP CONTACTED THE FACILITY'S BUYER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. THE FACILITY'S BUYER STATED THE FOLLOWING" THE OPERATING ROOM STAFF OPENED BOX AND NOTED THE SHEATH WAS SPLIT. THE DEVICE WAS NEVER USED AND WILL BE RETURNED TO THE MFR FOR EVALUATION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTEX WITH KIT VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. NA 990401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other