BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 872912 · Received June 27, 2007

    Report

    Report Number
    1710034-2007-00060
    Event Type
    Other
    Date Received
    June 27, 2007
    Date of Event
    June 5, 2007
    Report Date
    June 11, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED UNIT WAS RECEIVED ON 20 JUNE 2007 AND SENT FOR DECONTAMINATION. UPON DECONTAMINATION OF THE UNIT AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: JUNE 26, 2007.

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED IN THE RIGHT SAPHENOUS VEIN. THE CATHETER WAS INDWELLING ABOUT 3 OR 4 DAYS. THERE WERE NO DIFFICULTIES NOTED DURING INSERTION. IN 2007, ABDOMINAL DISTENTION WAS FOUND AND TPN FLUID WAS THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 6214173

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other TPN