BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK Y-TYPE BLOOD/SOLUTION SET

    MDR report key: 370734 · Received January 4, 2002

    Report

    Report Number
    6000001-2002-00010
    Event Type
    Malfunction
    Date Received
    January 4, 2002
    Date of Event
    December 1, 2001
    Report Date
    December 4, 2001
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS TUBING SEPARATION FROM THE DISTAL END LUER ATTACHMENT AT THE END OF THE INFUSION. ACCOUNT REPORTS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK Y-TYPE BLOOD/SOLUTION SET INTERLINK BLOOD SET KSB BAXTER HEALTHCARE CORPORATION NA UR108613

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN