BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 1833459 · Received August 24, 2010

    Report

    Report Number
    1833459
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BAXTER INTERLINK SET
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIRD PARTY REPORT: IV TUBING CONNECTIONS WERE LEAKING FROM THE THREADED, LUER-LOCK COLLAR, DISTAL CONNECTION (DISTAL MALE-FEMALE SITE). IT APPEARS TO BE A PLASTIC-VINYL CONNECTION (ALL OTHERS ON TUBING ARE PLASTIC-PLASTIC), NURSES HAVE NOTED THIS CONNECTION TO BE SEPARATED IN THE PACKAGING ON OCCASSIONS. CONCERN IS THE PREVALENCE OF THE CONNECTIONS SITES BECOMING LOOSENED, ESPECIALLY WITH PATIENT MOVEMENT, AND THESE CONNECTIONS REQUIRING THE NEED FOR MULTIPLE 'TIGHTENING' EVENTS TO STOP LEAKING. POSSIBLE THAT HAVING OPEN SLOTS IN THE LUER THREADS IS A CAUSE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================POSSIBLE DESIGN OF THE LUER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER IV EXTENSION TUBING FPA BAXTER INTERLINK SET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *