BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION

    MDR report key: 2021717 · Received March 14, 2011

    Report

    Report Number
    MW5019797
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 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

    PREMATURE NEWBORN INFANT 34 WEEKS, 7 HRS OLD, WITH RESPIRATORY DISTRESS NPO WITH D10 W INFUSING THRU BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION SET FELL APART AT CONNECTION, AT SINGLE CONNECTION LEADING TO PT. RN READ IV AT 1500 PRODUCT INTACT, RN MAKING ROUNDS AT 1520 DISCOVERED LARGE AMOUNT OF BLOOD ON LINEN. PRODUCT FOUND TO BE SEPARATED AS ABOVE. IV FLUSHED AND CLAMPED. INFANT IN NO ADDITIONAL DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION 3 LEAD IV EXTENSION SET FPA BAXTER 2N3341 ORIGINAL PACKAGE DISCARDED

    Patients

    Seq Age Sex Outcome Treatment
    1 7 HR Life Threatening