BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK I.V. CATHETER EXTENSION SET

    MDR report key: 755975 · Received October 24, 2005

    Report

    Report Number
    6000001-2005-05506
    Event Type
    Malfunction
    Date Received
    October 24, 2005
    Date of Event
    October 14, 2005
    Report Date
    October 24, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. IF IT IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED. SIMILAR INCIDENTS HAVE BEEN RECEIVED FOR THIS PRODUCT CODE, 2N3370. THIS INCIDENT HAS BEEN COMMUNICATED TO THE RESPONSIBLE BAXTER PERSONNEL TO REVIEW AND DETERMINE IF THIS DATA IS WITHIN THE EXPECTED LEVEL OF OCCURRENCE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    INTERNATIONAL COMPLAINT RECEIVED ON 10/21/2005. CUSTOMER REPORTS DURING PATIENT USE, A LEAK WAS OBSERVED BETWEEN THE TUBING AND THE FEMALE LUER. NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK I.V. CATHETER EXTENSION SET EXTENSION SETS FPA BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN