BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUAD T-CONNECTOR EXTENSION SET WITH NON-VENTED CAPS

    MDR report key: 8124081 · Received December 3, 2018

    Report

    Report Number
    8124081
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    October 5, 2018
    Report Date
    November 21, 2018
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    UDI-DI
    00813153021910
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD THE CODAN QUAD T CONNECTOR EXTENSION SET. ONE OF THE EXTENSION SITE PIECES THAT SHOULD NOT COME APART, CAME OUT OF THE EXTENSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964346 QUAD T-CONNECTOR EXTENSION SET WITH NON-VENTED CAPS SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 76.8089 76670 00813153021910

    Patients

    Seq Age Sex Outcome Treatment
    1 6570 DA