BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 1882447 · Received October 21, 2010

    Report

    Report Number
    9616066-2010-00286
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURNED, THE SET WAS DISCARDED BY THE FACILITY. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE CLEAR PLASTIC PART OF THE Y-BODY ON THE EXTENSION SET BROKE AND LEAKED. STATED IT WAS A NEW IV AND THE EXTENSION SET HAD BEEN IN USE ONLY A FEW HOURS. NO PT HARM REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET FPA CAREFUSION CORPORATION 20018E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK