Events

Field Safety Notices about Flexi-Slip™ Endotracheal Tube Stylet

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Teleflex 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
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Teleflex are recalling the products referenced above following receipt of reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. no patient injuries have been reported related to this issue. .

Device

Flexi-Slip™ Endotracheal Tube Stylet
  • Model / Serial
    FLEXI-SLIP ENDOTRACHEAL TUBE STYLET WITH SOFT DISTAL TIP 502501 Refer to Appendix 2 FLEXISLIP STYLET, STERILE PACK 503700-000060 503700-06
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical