BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3821523 · Received January 15, 2014

    Report

    Report Number
    9616066-2014-00033
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Report Date
    December 30, 2013
    Manufacturer
    CAREFUSION CORP.
    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

    (B)(4). CUSTOMER STATED THAT NO PRODUCT WOULD BE RETURNED. THE CUSTOMER'S REPORT OF SET LEAKED FROM FILTER VENT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    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
    40825 SMARTSITE EXTENSION SET FPA CAREFUSION CORP. 20029E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK