Events

Safety Alert Or Field Safety Notices for Primary PlumSet Clave secondary port

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 Hospira.

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/2013/079
  • Event Number
    CON335060
  • Event Date Posted
    2013-11-13
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON335060?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 interruption to iv therapy, which may require medical intervention. this is due to leakage of fluids from the break in the bond between the clave needle-free connector and the secondary port of the plumset.  hospira issued a field safety notice (fsn) dated 8 august 2013 to advise users how to minimise the possibility of breakage, but has not received confirmation from enough users that they have received and acted on this information.
  • Action
    Identify affected administration sets. Ensure that all users are aware of the recommendations given in the FSN. In particular, do not bend or twist the Clave needle-free connector when accessing the secondary port. Return the completed reply form to Hospira.

Device

Primary PlumSet Clave secondary port
  • Model / Serial
  • Product Description
    Intravenous administration sets: Primary PlumSet Clave secondary port. Specific list numbers are affected. All lots manufactured after July 2007 of the following list numbers have been supplied to the UK and are affected: 140010728 140018328 140019228 140149228 142129228 196735324 Note that any other list numbers detailed in the FSN have not been supplied to the UK
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA