BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERLINK CONTINU-FLO SOLUTION SET

    MDR report key: 524446 · Received February 10, 2004

    Report

    Report Number
    6000001-2004-00197
    Event Type
    Other
    Date Received
    February 10, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 9, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON MULTIPLE OCCASIONS LEAKAGE WAS NOTED FROM INJECTION SITES. REPORTEDLY, THIS IS NOTED DURING PATIENT USE. CLINICIAN STATED THAT CLINICIAN HAD AN INCIDENT WHERE CHEMO LEAKED ON THE FLOOR. NO REPORT OF INJURY OR MEDICAL INTERVENTION. LEAKAGE OCCURS WHEN PORT IS ACCESSED WITH BECTON-DICKINSON (BD) BLUNT PLASTIC CANNULA OR BAXTER SECONDARY SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO SOLUTION SET CONTINU-FLO SET FPA BAXTER HEALTHCARE CORP. NA S03K09022R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BLUNT PLASTIC CANNULA.| 2C7451 (SECONDARY MEDICATION SET) BY BAXTER BD