BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN PICC

    MDR report key: 2932976 · Received January 25, 2013

    Report

    Report Number
    MW5028765
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MARIAN MEDICAL, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PICC LINE NOTED TO BE LEAKING DURING ROUTINE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36123 GUARDIAN PICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS MARIAN MEDICAL, INC 12486

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA