Events

Safety Alert Or Field Safety Notices for Bivona® Neonatal, Pediatric and Flextend

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 Smiths Medical.

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/2012/002
  • Event Number
    CON140753
  • Date
    2012-01-19
  • Event Date Posted
    2012-01-19
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON140753?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
    Incorrectly connected accessories may be difficult to remove, requiring excessive force to disconnect.  this may cause the tube to dislodge, requiring it to be changed. the manufacturer has initiated a recall of affected tubes. the manufacturer issued a field safety notice (fsn) – dated 15 november 2011 – but has not had confirmation from all users that they have received and acted on this information.
  • Action
    See appendix one for affected reorder numbers, and NHS supply chain codes where applicable. Locate and quarantine all unused affected devices. Complete and return the Smiths Medical confirmation form, even if you no longer have affected units in stock. Return all unused affected devices as described in the Field Safety Notice issued by Smiths Medical. For patients with affected tubes in situ: Review the advice on correct use provided in the Customer Information Bulletin found in the FSN and the Tracheostomy – Neo-Pedi” guidance video (external link) on the Smiths Medical website.

Device

Bivona® Neonatal, Pediatric and Flextend
  • Model / Serial
  • Product Description
    Tracheostomy tubes: Bivona®  Neonatal, Pediatric and Flextend. Lot numbers from 1631477 to 1923406 inclusive. Only devices intended for neonatal and paediatric use are affected. Only tubes with an integrated connector that does not allow for use of a disconnect wedge (TR3) are affected. Examples of accessories that can be used with the affected tubes include: speaking valves, heat moisture exchangers, and breathing circuit connectors. A design modification was implemented in November 2010 to address this problem.
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical