BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK Y-TYPE CATHETER EXTENSION SET

    MDR report key: 33901 · Received July 3, 1996

    Report

    Report Number
    MW1009433
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Date of Event
    January 7, 1996
    Report Date
    June 21, 1996
    Manufacturer
    I.V. DIV. BAXTER HEALTHCARE CORP.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP. RT 120 & WILSON RD, ROUND LAKE, IL 60073-0490. ONE USED Y-TYPE EXTENSION, PRODUCT CODE 2N3371, SET WAS RECEIVED AT OUR FACILITY FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE SHOWED THAT THE TUBING HAD SEPARATED FROM THE MALE LUER LOCK ADAPTER DUE TO AN INSUFFICIENT SOLVENT BOND. THE LOT NUMBER OF THE SAMPLE INVOLVED COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK Y-TYPE CATHETER EXTENSION SET Y-TYPE CATHETER EXTENSION SET FOZ I.V. DIV. BAXTER HEALTHCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR