BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE 2FR

    MDR report key: 2469401 · Received February 16, 2012

    Report

    Report Number
    2245270-2012-00006
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    November 8, 2011
    Report Date
    February 16, 2012
    Manufacturer
    VYGON CORP.
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO VYGON US, BUT THE MFR IS CONDUCTING AN INVESTIGATION USING THE INFO PROVIDED BY THE CLINICIAN. A FOLLOW-UP MDR WILL BE SENT WITHIN THIRTY DAYS OF THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A CATHETER WAS INSERTED INTO A PT AND ONE HOUR AFTER INSERTION A FLUID CHANGE WAS PERFORMED. DURING THIS FLUID CHANGE THE CATHETER SLICED OFF AT THE EXTENSION LINE WHEN THE CLAMP WAS USED. THE CLINICIAN REPORTED THAT IT WAS SEEMINGLY THE CLAMP THE SLICED THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTRILINE 2FR CATHETER, LONG TERM, INTRAVASCULAR, PICC LJS VYGON CORP. 1252.35M 11E31

    Patients

    Seq Age Sex Outcome Treatment
    1