BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK IV CATHETER EXTENSION SET

    MDR report key: 1183215 · Received October 3, 2008

    Report

    Report Number
    6000001-2007-00140
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 19, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON JAN 03, 2007. UNUSED SAMPLES HAVE BEEN REQUESTED FOR EVALUATION. IF SAMPLES ARE RECEIVED AND EVALUATION PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED REPORT FROM NURSE INDICATING BLOOD WAS LEAKING ABOVE THE HUB ON THIS SET. PATIENT WAS BEING ADMINISTERED MTX WHEN INCIDENT OCCURRED. NURSE FOUND YELLOW SPOT OF MTX ON PATIENTS GOWN WHICH LEADS HER TO BELIEVE MTX WAS ALSO LEAKING OUT OF THE SET. NO PATIENT INJURY HAS BEEN REPORTED. SET WAS REPLACED AND PATIENTS MTX THERAPY CONTINUED. NO ADDITIONAL INFORMATION IS AVAILABLE ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK IV CATHETER EXTENSION SET EXTENSION SET FPA BAXTER HEALTHCARE CORPORATION N/A R06G20080

    Patients

    Seq Age Sex Outcome Treatment
    1