BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUTHER L-CATH

    MDR report key: 1822318 · Received August 9, 2010

    Report

    Report Number
    1822318
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S PICC LINE REQUIRED REPOSITIONING AS RESULT OF X-RAY EXAMINATION. WHEN THE DRESSING WAS REMOVED FROM THE CATHETER IT WAS NOTED THAT THE LAVENDER CATHETER STRAIN RELIEF HAD SEPARATED FROM THE LUER HUB AND SLID DOWN THE LENGTH OF THE CATHETER TUBING. CATHETER REPLACEMENT PROCEDURE PERFORMED WITHOUT INCIDENT. THE CATHETER WAS REMOVED AND SENT TO BIOMEDICAL ENGINEERING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUTHER L-CATH CATHETER, PICC LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC 26G30CM 9302296

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DAY