Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Covidien.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 112 07 12 000
  • Event Initiated Date
    2012-07-30
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2147
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. these events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. if a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.

Device

Shiley Reusable Cannula Low-Pressure Cuffed Tracheostomy Tubes
  • Model / Serial
    (1)8FEN Starting Lot Number: 0910000342 Ending Lot Number: 1101001558 Starting Lot Number: 110201893X Ending Lot Number: 120600700X (2)8LPC Starting Lot Number: 0910000346 Ending Lot Number: 1101001823 Starting Lot Number: 110200327X Ending Lot Number: 120600351X (for more code see attached)
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Tracheostomy Tubes,mechanical ventilation
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA