BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN PICC

    MDR report key: 2169785 · Received July 11, 2011

    Report

    Report Number
    2169785
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    March 19, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MARIAN MEDICAL, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    A VOLUNTEER WAS HOLDING THE BABY WITH THE PICC LINE, WHICH HAD BEEN CHECKED BY THE RN PRIOR TO THE VOLUNTEER PICKING IT UP. AT THAT TIME, THE LINE WAS CLEAR, PATENT, DRY, AND INTACT. AS THE VOLUNTEER WAS PUTTING THE BABY BACK INTO THE CRIB ABOUT 1/2 HOUR LATER, THE RN NOTICED BLOOD ON THE BABY'S BLANKET. UPON INVESTIGATION, THE PICC WAS FOUND TO BE LEAKING AND BLOODY. ANOTHER RN AND NNP CAME TO ASSIST. AT THIS TIME, THE PICC WAS DISCOVERED TO BE BROKEN AND THE NNP REMOVED IT PER PROTOCOL. THE CATHETER WAS PATENT AND INTACT WHEN REMOVED. THE LENGTH OF THE CATHETER WAS 14 CM WHICH MATCHED THE LENGTH UPON INSERTION. PRESSURE WAS HELD AT THE SITE WITH VERY LITTLE BLEEDING NOTED. A LEAK WAS FOUND DIRECTLY ABOVE THE "HEART" WHICH IS THE RUBBER PIECE THAT SITS OUTSIDE THE BABY'S BODY, AND WHERE STERI STRIPS ARE PLACED ON IT TO SECURE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN PICC CATHETER, PICC LJS MARIAN MEDICAL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO