Safety Alert: Vygon Nutriline Twinflo

BAPM has received reports of the guide wire of the Vygon twin line snapping from the stylet on their removal. While we are not currently aware of any direct harm as a result, there is potential of harm and had led to some lines being removed urgently resulting in the need for reinsertion.

Please contact the manufacturer if you experience any problems. 

BAPM also strongly advises you to send in a Yellow Card report for medical device issues for these products.

Vygon have provided the following statement:

Patient safety remains our highest priority, and we take all concerns with the utmost seriousness.

We would like to thank BAPM for issuing their safety alert, instructing clinicians and users to contact Vygon (UK) Ltd directly should any problems arise. We also strongly encourage the reporting of incidents to the MHRA via the Yellow Card reporting site. However, if there are any customers who would like further support or training with this product, please contact the Technical team directly on [email protected] / 01793 748800 so we can arrange this.

Following a thorough investigation of the incidents reported to Vygon, conducted in collaboration with the legal manufacturer, we can confirm that no manufacturing or material-related issues have been identified. From previous investigations, we are aware of two potential factors that may influence the withdrawal of the stylet. These factors can create resistance during removal attempts, increasing the likelihood of separation or fracture:

• Inadvertent application of direct pressure over the catheter when the stylet is in place.
• The potential of the stylet (which is hydrophilic) to absorb only a small amount of fluid that had been used to prime the line. This can again affect withdrawal by a dry section ‘grabbing’ the catheter. Removal can be eased by gentle flushing of the catheter via the side-port to (re)lubricate the stylet within the catheter.

The legal manufacturer, Vygon GmBH, provides the following advice for removing the stylet

Neonatal longlines - Tips for easier retrieval of the stylet

1. Before catheter placement

Flush the catheter at the proximal end using a 10ml syringe.

2. During catheter placement

Flush the catheter again. 

Do not bend or kink the catheter with the stylet in place. 

The exterior portion of the catheter should be kept in a straight line.

3. During stylet retrieval

Remove the stylet slowly, ensuring you keep even tension. If difficulty is experienced removing the stylet, stop and let the vein rest for a minute and then try removal again very slowly. Gentle flushing of catheter assists in stylet removal.

Do not use syringes smaller than 10m

Small volume syringes (1ml - 5ml) will result in excessive pressure being exerted and may result in damage to the longline.