BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-CONNECTOR

    MDR report key: 494639 · Received November 7, 2003

    Report

    Report Number
    1526863-2003-00105
    Event Type
    Malfunction
    Date Received
    November 7, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 9, 2003
    Manufacturer
    MEDEX
    Product Code
    FKB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE "T" CONNECTOR IS SEPARATING FROM THE BACK OF THE ACUVANCE CATHETER. NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-CONNECTOR T-CONNECTOR FKB MEDEX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN