Recall of BD Venflon Pro safety and Venflon Pro IV cannula (DSI/2021/006R)

Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.

From:
Medicines and Healthcare products Regulatory Agency
Published
4 May 2021
Last updated
20 May 2021 — See all updates
Message type:
Device safety information
Medical specialty:
Anaesthetics, Cardiology, Cosmetic surgery, Critical care, General surgery, Haematology and oncology, Obstetrics and gynaecology, Orthopaedics, Paediatrics, Radiology, Renal medicine, Theatre practitioners, Urology, Vascular and cardiac surgery
Issued:
4 May 2021

Becton Dickinson (BD) has identified an increase in reports of leakage from the injection port for EtO sterilised devices of BD Venflon Pro Safety (VPS) Needle Protected IV Cannula and BD Venflon Pro IV Cannula.

BD has updated its Field Safety Notice (FSN) information and is now also recalling Venflon Pro products sterilised by ethylene oxide (EtO). It does not affect products sterilised by electron beam.

Check both the FSNs for affected product codes and details on how to identify sterilisation methods used: BD Venflon Pro safety IV cannula FSN BD Venflon Pro IV Cannula FSN

Risk involved with using affected product

There is a risk of blood or fluid loss from the injection port, which can result in serious harm if undetected.

Reported issues to date include:

  • minor to severe blood loss
  • delay to treatment
  • failure of cannula leading to replacement
  • non-delivery of critical medications

Information from the manufacturer indicates an increased risk with larger cannulae and if the devices are used in combination with rapid pressurised fluid infusers.

Actions for NHS Trusts or equivalent and private healthcare providers

  1. Identify and procure suitable alternative vascular access devices.

  2. Ensure that there is adequate supply of alternatives in clinical areas to maintain care provision.

  3. Ensure clinicians are informed of the change.

  4. Follow recall actions in the Venflon Pro Safety FSN and Venflon Pro IV Cannula FSN. Always act on FSNs issued by manufacturers. Do not wait for a communication from the MHRA.

  5. Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

  6. Sign up to receive email updates on alerts and device safety information from the MHRA.

Published 4 May 2021
Last updated 20 May 2021 + show all updates

  1. The manufacturer has extended the recall to also include specific catalogue numbers the BD Venflon Pro™ IV Cannula.

  2. First published.