BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET

    MDR report key: 2343415 · Received November 4, 2011

    Report

    Report Number
    2343415
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 4, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PRIMARY NUTRITION TUBING SET (LIST NUMBER 12539-05) WAS FOUND TO HAVE A HOLE IN IT. THIS WAS NOTED WHEN THE RN ATTEMPTED TO PRIME TOTAL PARENTERAL NUTRITION (TPN) THROUGH THE TUBING AND FOUND THAT IT LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET INTRAVASCULAR TUBING FPA HOSPIRA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *