Events

Safety Alert Or Field Safety Notices for Riata and Riata ST – all silicone coated models

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 St Jude 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/2013/027
  • Event Number
    CON270680
  • Date
    2013-05-01
  • Event Date Posted
    2013-05-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON270680?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
    Improper use of peritoneal dialysis transfer sets may result in contamination, leading to infection or peritonitis. baxter healthcare ltd issued a field safety notice (fsn) in march 2013 to communicate various changes to the instructions for use (ifu).
  • Action
    Identify affected devices. Ensure that all staff, who are responsible for placing and maintaining peritoneal dialysis transfer sets, are aware of the manufacturer’s FSN and the changes to the IFU. Ensure that all patients with these devices, who maintain their own transfer set, are aware of the patient advice in the FSN. This includes: the importance of maintaining aseptic technique. the appropriate use of chemical agents. that the use of excessive force can result in damage to the twist clamp. Return the customer reply form in the FSN to the manufacturer. The MHRA has previously issued advice on disinfecting and cleaning reusable medical devices with plastic surfaces to prevent damage.  See MDA/2013/019.

Device

Riata and Riata ST – all silicone coated models
  • Model / Serial
  • Product Description
    Implantable cardioverter defibrillator (ICD) leads. Riata and Riata ST – all silicone coated models.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA