BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 3821525 · Received January 15, 2014

    Report

    Report Number
    9616066-2014-00036
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    November 11, 2013
    Report Date
    December 23, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPB
    PMA / PMN Number
    K801614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 01/15/2014. (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PRODUCT WAS RECEIVED BY CAREFUSION UNEXPECTEDLY. A NOTE WITH THE RETURNED PRODUCT STATED: "FILTER LEAKS. SECOND FILTER LEAKING IN PAST TWO DAYS." THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40824 SMARTSITE EXTENSION SET FPB CAREFUSION CORP. 20029E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK