BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 260744 · Received February 3, 2000

    Report

    Report Number
    1056436-2000-00002
    Event Type
    Injury
    Date Received
    February 3, 2000
    Date of Event
    December 27, 1999
    Report Date
    January 4, 2000
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 01/04/2000, THE DISTRIBUTOR'S MARKETING MANAGER INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: ON 01/04/2000, THE FACILITY'S O.R. NURSE STATED THAT THE PHYSICIAN EXPLANTED THE DEVICE BECAUSE THE ONCOLOGIST SAID THAT THE DEVICE WAS NOT WORKING PROPERLY. THE DEVICE WAS REMOVED AND ONLY A SMALL PORTION OF THE DEVICE CATHETER WAS ATTACHED. THE PT WAS X-RAYED TO DETERMINE LOCATION OF THE REMAINDER OF THE CATHETER. THE CATHETER WAS FOUND ON A VESSEL. EVERYTHING WAS REMOVED. CATALOG/LOT NUMBER OF THE DEVICE WAS UNKNOWN. THE DISTRIBUTOR'S MARKETING MANAGER STATED THAT THIS FACILITY USUALLY PURCHASES LPS7513, BUT WAS UNCERTAIN OF THE PRODUCT NUMBER OF THE DEVICE IN QUESTION. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention