BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CATHETER EXTENSION SET

    MDR report key: 565437 · Received January 7, 2005

    Report

    Report Number
    6000001-2005-00015
    Event Type
    Malfunction
    Date Received
    January 7, 2005
    Date of Event
    December 10, 2004
    Report Date
    December 10, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER NATIONAL COORDINATOR RECEIVED COMPLAINT FROM CUSTOMER REGARDING THE SEPARATION OF THE TUBING FROM MALE CONNECTOR ON THIS SET. NO PT INJURY HAS BEEN REPORTED AT THIS ITME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CATHETER EXTENSION SET EXTENSION SETS FOZ BAXTER HEALTHCARE CORP. NA UR203947

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN