BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3821515 · Received January 15, 2014

    Report

    Report Number
    9616066-2014-00030
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 30, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K801614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NO: (B)(4). THE SET HAS BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAKED FROM THE VENT ON THE FILTER OF AN EXTENSION SET. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41042 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 20029E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK