The Medicines & Healthcare Products Regulatory Agency (MHRA) has issued a medical device safety alert concerning Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip (Product code: 502501) and Flexislip Stylet Sterile Pack (Product codes: 503700-000060, 503700-06) manufactured by Teleflex Medical.
The manufacturer has received 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.
According to the manufacturer, no patient injuries have been reported related to this issue.
Users are advised to quarantine and cease use of the affected products.
For details, please refer to the TGA website:
https://mhra.filecamp.com/public/file/29qi-f3qkkkq2
If you are in possession of the affected products, please contact your supplier for necessary actions
Posted on 2 September 2015