BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE Y-EXTENSION SET

    MDR report key: 1211188 · Received October 10, 2008

    Report

    Report Number
    1211188
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    CENTRAL LINE TUBING BECAME CAUGHT AND THE Y-CONNECTOR CAME APART. THIS OCCURRED WHERE THE TUBING CONNECTS TO THE LUER LOCK END THAT CONNECTS TO CENTRAL LINE "HUB." THERE WAS NO HARM TO THE BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALLBORE Y-EXTENSION SET TUBING, IV FPA B. BRAUN MEDICAL, INC. ET07US *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO