BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASAFE SPLIT SEPTUM SET

    MDR report key: 3944164 · Received May 7, 2014

    Report

    Report Number
    9616066-2014-00445
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 22, 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). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SPLIT SEPTUM PORT WAS PUSHED INTO THE TUBING AND OCCLUDED THE SET. THIS OCCURRED WHEN ACCESSING THE PORT WITH A BLUNT NEEDLE, WHILE TRYING TO ADMINISTER AN IV PUSH MEDICATION. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275001 VERSASAFE SPLIT SEPTUM SET FPA CAREFUSION CORPORATION 10796814 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL 9391-0200, LOT UNK| VERSASAFE SPLIT SEPTUM PLASTIC CANNULA: