BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 1111788 · Received August 12, 2008

    Report

    Report Number
    MW5007974
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH A BARD GROSHONG NXT 5 FR PICC LINE IN HIS LEFT UPPER ARM. LINE WAS INSERTED IN 2008. IN THE NEXT DAY, CALLED TO EVALUATE "LEAKING PICC LINE." WHEN CATHETER FLUSHED FLUID LEAKED OUT INSERTION SITE UNDERNEATH THE DRESSING. LINE WAS REMOVED INTACT AND NEW PICC LINE WAS PLACED IN THE LEFT UPPER ARM. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: ADMINISTRATION OF IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD GROSHONG LJS BARD ACCESS SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR