- Identify affected devices and check that the safety cap is attached to the needle (see manufacturer’s Field Safety Notice dated 3 October 2019).
- If the safety cap is not in place, dispose of devices in line with your local procedures.
- Contact Teleflex to have your account credited.
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Users of the device and those responsible for procurement/stock management.
Deadlines for actions
Actions underway: 14 January 2020
Actions complete: 28 January 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
The affected product codes are listed in the manufacturer’s Field Safety Notice.
In addition, for some of the affected product codes these are the National Supply Chain codes for England:
||Secondary Product Description
||15G x 45mm Yellow with stabilizer Dressing Extension Set Patient Wrist Band and Sharps Block
||15G x 25mm Blue with stabilizer Dressing Extension Set Patient Wrist Band and Sharps Block
||15G x 15mm Pink with stabilizer Dressing Extension Set Patient Wrist Band and Sharps Block
In addition to the manufacturer’s Field Safety Notice, which details affected product, the table below gives the unique device identifier codes for some of the products.
|Device Identifier GTIN
||Catalogue number (Manufacturer product code)
|Single: 00816000011898, Pack: 10816000011895, Case: 20816000011892
||15mm Needle + Stabilizer Kit (9018P)
|Single: 00816000011881, Pack: 10816000011888, Case: 2081600001188
||25mm Needle + Stabilizer Kit (9001P)
|Single: 00816000011904, Pack: 10816000011901, Case: 20816000011908
||45mm Needle + Stabilizer Kit (9079P)
Tel: 01494 532 761
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Adult intensive care units
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- IV nurse specialists
- Supplies managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/046 or 2019/010/003/487/012.
Enitan Taiwo or Eliz Mustafa, MHRA
Tel: 020 3080 6000
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)
Tel: 028 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can't access the webform, visit the website: how to report an adverse incident
Population Healthcare Division, Welsh Government
Tel: 03000 255278 or 03000 255510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).