BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 5056428 · Received September 4, 2015

    Report

    Report Number
    5056428
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 2015
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED A 22-GAUGE SALINE LOCK IN THE PATIENT'S RIGHT HAND, NOTICED A SMALL AMOUNT OF BLOOD ON PATIENT'S HAND. UPON ATTEMPTING TO FLUSH, NOTED SALINE/BLOOD COMING OUT OF THE TOP OF THE HOUSING. UPON FURTHER INSPECTION (AFTER REMOVAL) FOUND A SMALL BREAK IN THE HOUSING. BD NEXIVA 22GAUGE 1INCH, LOT#5133991, EXPIRATION: 05/2018. MANUFACTURER RESPONSE FOR BD NEXIVA IV CATHETER 22 GA 1.00IN, BD NEXIVA (PER SITE REPORTER): NONE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588158 NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5133991

    Patients

    Seq Age Sex Outcome Treatment
    1 NO