Events

Safety Alert Or Field Safety Notices for BD Neoflon™ IV cannula

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Becton Dickinson.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/074
  • Event Number
    CON322755
  • Date
    2013-10-10
  • Event Date Posted
    2013-10-10
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON322755?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of delay in treatment due to increased risk of the catheter buckling during initial puncture of skin. due to a change in manufacturing process, the manufacturer has become aware of an increase in reported incidents of the catheter buckling in use. becton dickinson does not currently have stock available to replace affected devices. new product is being manufactured and should be available for supply from the beginning of october. becton dickinson has not issued a field safety notice in relation to this issue.
  • Action
    Ensure staff are aware of this potential problem. Exercise additional care and vigilance when using this product and, if possible, use alternative devices until new product is available from Becton Dickinson. Report any incidents of devices buckling to the MHRA.

Device

BD Neoflon™ IV cannula
  • Model / Serial
  • Product Description
    BD Neoflon™ IV cannula All lots of: Product code: 391350, size: 24 G, NHSSC code: FSP070 Product code: 391349, size: 26 G. This is a disposable device designed to gain access to peripheral veins of the patient’s blood system for rehydration, parenteral nutrition, medication delivery, blood transfusion and monitoring purposes.  This device is intended for use on neonatal, paediatric and geriatric patients.
  • Manufacturer
    Becton Dickinson

Manufacturer

Becton Dickinson