BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFUSE-A-CATH CENTRAL VENOUS CATHETER

    MDR report key: 250734 · Received November 18, 1999

    Report

    Report Number
    1056436-1999-00193
    Event Type
    Other
    Date Received
    November 18, 1999
    Date of Event
    October 20, 1999
    Report Date
    October 20, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/20/1999, THE INTERNATIONAL DISTRIBUTOR INFORMED THE MFR'S INTERNATIONAL REPRESENTATIVE OF THE FOLLOWING: THE DESCRIPTION ON THE LABEL OF THE PRODUCT DOES NOT FIT WITH THE PRODUCTS CONTAINED IN THE PACKAGING. IT SEEMS THE TUNNELER AND THE INTRODUCER KIT WERE NOT IN THE PACKAGE. THERE WAS A QUESTION AS TO WHETHER EVERYTHING SHOULD BE IN ONE (1) TRAY OR IN DIFFERENT BOXES PACKED TOGETHER. ON 10/22/1999, THE MFR'S INTERNATIONAL REPRESENTATIVE INFORMED THE MFR THAT THE CUSTOMER CONTACTED HIM (10/22/1999) AND STATED THAT THE LABELING ON THE TOP OF FIVE (5) THE BOX/PACKAGES STATES THAT THE BOX CONTAINS A 7 FRENCH INTRODUCER AND THE SIDE LABEL STATES THAT THE BOX CONTAINS A 5 FRENCH. THE INTERNATIONAL DISTRIBUTOR IS RETURNING TEN (10) OF THE DEVICES IN QUESTION TO THE MFR FOR EVAL. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE-A-CATH CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER DQO HORIZON MEDICAL PRODUCTS, INC. NA 14798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other