BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 2232627 · Received August 26, 2011

    Report

    Report Number
    1710034-2011-00075
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 26, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVAL. ADDITIONAL INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE CATHETER WAS PLACED INTO HIS LEFT ARM ON (B)(6), 2011. THERE DID NOT SEEM TO BE ANY PROBLEMS DURING CATHETER INSERTION. THE PT WAS UNSURE OF WHAT DEVICE WAS BEING USED, HOWEVER, HE CONFIRMED THE DEVICE HAD A BUTTERFLY AND THE FACILITY IS A CONFIRMED BD NEXIVA USER. THE PT WAS THEN ADMITTED TO THE HOSPITAL ON (B)(6) 2011 FOR AN INFECTION. THE PT BELIEVES THAT THE INFECTION STARTED AROUND THE (B)(6). THE PT WAS DIAGNOSED WITH MRSA SINCE (B)(6) 2011 AND HAS BEEN WALKING WITH AN IV PEAK AND A DRAIN IN HIS LEG. THE PT STATED THAT THE EMERGENCY ROOM PERSONNEL NOTED THAT THE INFECTION WAS FROM THE IV. THE PT HAS LOST TIME AT WORK AND SCHOOL AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other