BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH SINGLE LUMEN 3F

    MDR report key: 1962903 · Received December 30, 2010

    Report

    Report Number
    1962903
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    RN STAFF REPORTED LEAKING FROM LINE. ON ARRIVAL TO BEDSIDE, THE RN WAS ABLE TO VISUALIZE PICC LINE UNDER INTACT DRESSING. PICC LINE NOTED TO BE COMPLETELY DETACHED FROM CATHETER HUB. PATIENT STILL REQUIRING IV DRIP AND INTERMITTENT PIV MEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH SINGLE LUMEN 3F CATHETER, PICC LJS BD MEDICAL * 9232069

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES