BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR

    MDR report key: 8357266 · Received February 21, 2019

    Report

    Report Number
    8357266
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    February 8, 2019
    Report Date
    February 8, 2019
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN WENT TO RE-ATTACHED PPN / LIPIDS TO PATIENT'S PIV. IV TUBING ATTACHED SECURELY. WHEN RN LET GO OF IV TUBING, TUBING FELL ONTO FLOOR. PORTION THAT CONNECTS THE IV TUBING TO THE PIV WAS STILL ATTACHED TO PATIENT'S PIV, TUBING WITHOUT END SECUREMENT PORTION NOTED TO BE ON FLOOR. PPN / LIPIDS REMAIN OFF AT THIS TIME. RESIDENTS CONTACTED BY OTHER RN WHO WITNESSED THE TUBING MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151187 SET, ADMINISTRATION, INTRAVASCULAR FPA 1OMF5698

    Patients

    Seq Age Sex Outcome Treatment
    1