Becton Dickinson Venflon Pro™ IV Cannula (ICN 1277)

NHSSC 19

Alert: 

• Beckton Dickinson (BD) has issued a Field Safety Notice to remove BD Venflon Pro™ I.V. Cannulae.
• BD has confirmed an increase in reports for leakage from the injection port of the BD Venflon Pro™  I.V. Cannula.
• The identified root cause is the change to EtO sterilization.
• The leakage could result in a critical clinical impact if the leak is undetected for a period of time, as it has the potential to result in blood loss or inadequate infusion of the infusate.
• This could result in serious harm or even life-threatening conditions or death.
• BD has also issued a Field Safety Notice regarding Venflon Pro™  Safety Needle Protected I.V. Cannula, MDS-20-3801, details of this notice can be found in ICN 1218. (Please see our Useful Links ? section)

Products Affected:

• There are five affected products available via NHS Supply Chain:

NPC	Product Description	Supplier Code/MPC
FSN052	VENFLON PRO 14GA 2.0MM OD 45MM L	393210
FSN050	VENFLON PRO 16GA 1.8MM OD 45MM L	393209
FSN049	VENFLON PRO 18GA 1.3MM OD 45MM L	393207
FSN048	VENFLON PRO 20GA 1.1MM OD 32MM L	393204
FSN047	VENFLON PRO 22GA 0.9MM OD 25MM L	393202

• Please see our Downloads ▼ section to refer to the Field Safety Notice and Product Listing for further information on the affected product codes.

Customer Actions:

• Ensure that suitable alternatives are available to maintain care provision, once in place, withdraw and dispose of affected product at the earliest opportunity.
• Follow the instructions in the Field Safety Notice.
• If you require BD to collect and dispose of your impacted products, please indicate this in the customer reply form.
• Circulate the notice to all within your organisation who may use the affected products.
• Complete and return the Customer Reply Form on page 3 of the Field Safety Notice to BDUKFieldAction@bd.com as soon as possible but no later than 17 June 2021. It is important you return this form even if you no longer use the product.
• Contact your local NHS Supply Chain Customer Service Advisor with details of destroyed products to enable us to manage any customer credits on your behalf, as appropriate.

Next Steps:

• Where required, potential indirect alternative products are available to order through our online catalogue. Please refer to the Product Listing for information on alternative products.
• Safety Ported Cannulae alternatives are available should Clinicians want to consider these, for example below are BD products:
  SP5001, FSP5002, FSP5003, FSP5004, FSP5005.
• Other Safety Ported Cannulae are available on this Framework.
• These products will be demand managed with a total weekly threshold that has been set based on existing usage to ensure fair allocation and smooth demand.
• Systemically the thresholds are set daily based on a division of the total weekly threshold to give the daily quantity that can be ordered up to.
• Customers are advised to order small quantities regularly to meet your clinical needs. The restrictions may mean customers have to order daily to meet their weekly requirement.
• Customers will not be able to place bulk orders to replace all BD impacted stock at once.
• Manage orders locally through a reduced number of requisition points. The order restrictions are made at an organisation level, which may mean product is delivered to different requisition points in the organisation and not others.
• To best manage the disruption locally, customers should consider which requisition points are used to order these products to enable effective distribution of product across the organisation.
• Customers will be contacted by Customer Services if their order has been amended.

If you have any further questions, please contact BDUKFieldAction@bd.com, your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.