BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION KIT

    MDR report key: 2021714 · Received March 14, 2011

    Report

    Report Number
    MW5019795
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BAXTER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 AT 0230, RN PROVIDING ROUTINE CARE FOR PRE-TERM .847 GRAM BABY NOTICED SEPARATION OF BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION SET HAD SEPARATED AT Y JUNCTURE WHERE THE DOUBLE TUBING CONNECTS AT THE Y JUNCTURE. D7.5TPN WITH 20% INTRALIPIDS INFUSING. LINE WAS CONNECTED TO A PICC LINE. TUBING IMMEDIATELY DISCONNECTED PICC LINE FLUSHED. NO BLOOD LOSS ESTIMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION KIT 3 LEAD EXTENSION SET FPA BAXTER 2N3341 ORIGINAL PACKAGE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Life Threatening