BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK HIGH FLOW RATE EXTENSION SET

    MDR report key: 1170896 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-00152
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 14, 2006
    Report Date
    December 7, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF DEVICE IS RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE RECEIVED A MEDWATCH FROM THE CUSTOMER. CUSTOMER REPORTED UPON COMPLETION OF INFUSION, LINE WAS DISCONNECTED FROM 10 YEAR FEMALE PATIENT. TIP OF THE MALE LUER LOCK ADAPTOR CRACKED OFF REMAINING IN THE PATIENTS CAP ON THE END OF THE CENTRAL VENOUS LINE. CAP ON THE END OF THE CVL WAS CHANGED. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK HIGH FLOW RATE EXTENSION SET INTERLINK EXTENSION SET FPA BAXTER HEALTHCARE CORPORATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR