Events

Safety Alert Or Field Safety Notices for Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits

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/2014/036
  • Event Number
    CON456001
  • Date
    2014-09-17
  • Event Date Posted
    2014-09-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON456001?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 extubation or delay to therapy as there may be difficulty passing a suction catheter through the endotracheal tube when the holder is locked. there may also be difficulty locking the holder. this is due to a manufacturing problem, which means the holder might compress the endotracheal tube. smiths medical has issued a field safety notice (fsn) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.
  • Action
    Identify affected devices as described in the FSN and quarantine them. Complete and return the confirmation form in the FSN. Arrange for replacement devices with Smiths Medical.

Device

Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in in...
  • Model / Serial
  • Product Description
    Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits. Specific product codes and lot numbers. If relevant to you, the national supply codes are as follows: Scotland SKU: Smiths code NDC code H4001PS 054220 H4001S 007424 H4002PS 014408 H4002S 039364 H4051 - H4052 - England NPC: use manufacturer’s codes in the FSN Northern Ireland: use manufacturer’s codes in the FSN Wales NSV: use manufacturer’s codes in the FSN
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical