BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASAFE SPLIT SEPTUM SETS

    MDR report key: 4161011 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00694
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 13, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV TUBING SEPARATED FROM A SMARTSITE PORT DURING PT USE. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430727 VERSASAFE SPLIT SEPTUM SETS ACCESS DEVICE FPA CAREFUSION CORPORATION 10796814 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK