BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3883812 · Received February 12, 2014

    Report

    Report Number
    9616066-2014-00133
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 23, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K801614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER'S REPORT OF TPN LEAKED FROM FILTER COULD NOT BE CONFIRMED DUE TO PRODUCT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TPN LEAKED FROM THE FILTER ON A PT ON THE GENERAL PEDIATRIC FLOOR. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94277 SMARTSITE EXTENSION SET FPA CAREFUSION CORP 20029E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK