Events

Recall of Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00412-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00412-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Covidien is conducting this recall following reports from customers where patients who recently switched from the current shiley neonatal and pediatric products to these affected products as listed above, 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 also observed immediately after the switch. in all reported cases, patients were administered immediate medical attention. serious injuries, events that required medical intervention, have occurred or could occur due to the failure mode associated with this recall. there have been 12 reports of serious injuries. no deaths have been reported.
  • Action
    Covidien is requesting hospitals to discontinue use and quarantine all affected devices. Covidien will organise for the recovery of the affected devices. If one of the recalled Shiley tracheostomy tubes is currently in use in a patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, Covidien recommends that the patient’s physician evaluate the continued use.

Device

Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
  • Model / Serial
    Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard CuffNeonatal -Tracheostomy Tube Cuffless 2.5NEF, 3.0NEF, 3.5NEF, 4.0NEF & 4.5NEF-Tracheostomy Tube with TaperGuard Cuff2.5NCF, 3.0NCF, 3.5NCFPediatric -Tracheostomy Tube Cuffless 2.5PEF, 3.0PEF, 3.5PEF, 4.0PEF, 4.5PEF, 5.0PEF, 5.5PEF-Tracheostomy Tube Long Cuffless5.0PELF, 5.5PELF, 6.0PELF, 6.5PELFAll lot numbers beginning with 12, 13 and 14 & 15A0152JZX & 15A0154JZX
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 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
    DHTGA