Events

Safety Alert for Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Covidien.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-05-15
  • Event Date Posted
    2015-05-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150515.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: covidien shiley neonatal, paediatric and long paediatric tracheostomy tube, cuffless and with taperguard cuff australian therapeutic goods administration (tga) posted a medical device safety alert concerning shiley neonatal, paediatric and long paediatric tracheostomy tube, cuffless and with taperguard cuff, manufactured by covidien. the affected devices are identified as follows:- the affected devices are identified as follow:- neonatal tracheostomy tube cuffless: 2.5nef, 3.0nef, 3.5nef, 4.0nef & 4.5nef tracheostomy tube with taperguard cuff: 2.5ncf, 3.0ncf, 3.5ncf pediatric tracheostomy tube cuffless : 2.5pef, 3.0pef, 3.5pef, 4.0pef, 4.5pef, 5.0pef, 5.5pef tracheostomy tube long cuffless: 5.0pelf, 5.5pelf, 6.0pelf, 6.5pelf all lot numbers beginning with 12, 13 and 14 & 15a0152jzx & 15a0154jzx the manufacturer is conducting this recall following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to the affected products experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were observed immediately after the switch. serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. the manufacturer is requesting hospitals to discontinue use and quarantine all affected devices. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00412-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2015.

Device

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Medical Device Safety Alert: Covidien Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • 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.
  • Source
    DH