Events

Safety Alert Or Field Safety Notices for Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)

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 Vygon.

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/2014/045
  • Event Number
    CON482907
  • Date
    2014-12-05
  • Event Date Posted
    2014-12-05
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON482907?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 incorrect placement of catheter and delay to treatment. this is due to a manufacturing problem resulting in: decreased length of the catheter. the catheter tip may not reach the desired position during placement. catheters with four lumens (instead of five). this may then require additional catheter or extension sets after placement. vygon has issued a field safety notice (fsn), dated 16 september 2014, to its customers recalling affected catheters but has not received enough replies to assure themselves that users have received and acted on this information.
  • Action
    Identify and quarantine affected catheters. Complete the confirmation form in the FSN to arrange for replacement catheters if necessary. Return the form to the manufacturer. All those responsible for the purchase and use of this device.

Device

Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm)
  • Model / Serial
  • Product Description
    Central Venous Catheters: Multicath Expert 5 Lumen (9.5FG/16cm). Product Code: 8159.167 Lot/Batch number: 020414GE If relevant to you, the national supply codes are as follows: England NPC: FSU144 . Northern Ireland: Device supplied by PaLS as a 'Non Stock Item' Scotland SKU: NP106/12 Wales NSV: FSX0677
  • Manufacturer
    Vygon

Manufacturer

Vygon