BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK EXTENSION SET

    MDR report key: 286876 · Received July 19, 2000

    Report

    Report Number
    6000001-2000-00402
    Event Type
    Malfunction
    Date Received
    July 19, 2000
    Date of Event
    June 1, 2000
    Report Date
    June 19, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS TWO INCIDENTS IN WHICH LEAKAGE HAS OCCURRED FROM THE FILTER DURING CHEMO ADMINISTRATION. THE FOUR LOT NUMBERS PRESENT ON THE CUSTOMER'S SHELF ARE: Z225433, Z206169, Z212654, AND Z225011. NO PT COMPROMISE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK EXTENSION SET EXTENSION SET FPA BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN