Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes
Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.
Action
- Identify affected devices, distributed from July 2018 to April 2019 inclusive, as listed in the manufacturer's Field Safety Notice (FSN). NHS Supply Chain codes are provided on page 2 of this alert.
- Follow actions recommended in the manufacturer's FSN.
- 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.
Action by
- Laboratory director / manager
- Pathologists
- Point of care testing co-ordinators
- Purchasing and supplies managers
- Paediatric medical and nursing staff
Deadlines for actions
Actions underway: 07 August 2019
Actions complete: 21 August 2019
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.
Device details
Details of affected product, including NHS Supply Chain codes:
| Product Name | Product Code | NHS Supply Chain code | Lot |
|---|---|---|---|
| BD Microtainer®Z Tubes | 365964 | KCM058 | 8212774 |
| BD Microtainer® LH Tubes | 365966 | KCM062 | 821472N |
| BD Microtainer®SST™ Tubes | 365968 | KCM059 | 8086508 |
| 8086517 | |||
| 8129651 | |||
| 8173674 | |||
| 8178701 | |||
| 8178708 | |||
| 8220936 | |||
| 8284578 | |||
| BD Microtainer®K2E Tubes | 365975 | KCM002 | 8201643 |
| 8201645 | |||
| 8204883 | |||
| 8241537 | |||
| 8253627 | |||
| 8253658 | |||
| BD Microtainer®SST™ Amber Tubes | 365979 | KCM060 | 8180719 |
| 8264509 | |||
| 8282816 | |||
| BD Microtainer®PST™ LH Tubes | 365986 | KCM063 | 808582N |
| 808586N | |||
| 813766N | |||
| 821893N | |||
| 827650N | |||
| BD Microtainer®PST™ LH Amber Tubes | 365988 | KCM064 | 819351N |
| 822560N | |||
| 826456N | |||
| 827756N | |||
| BD Microtainer®FE Microcollection Tubes | 365993 | KCM067 | 8213607 |
| 8213615 |
Manufacturer contacts
Becton Dickinson
Contact Name: Kaye Glaysher
Mobile: 07818 579 088
Email: BDUKFieldAction@bd.com
Distribution
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
- All departments
- All staff
- All wards
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Anti-coagulation clinics
- Biochemists
- Biomedical science departments
- Cardiologists
- Clinical pathologists
- Clinical pathology directors
- Community children's nurses
- Community hospitals
- Community nurses
- Coronary care departments
- Coronary care nurses
- Day surgery units
- District nurses
- Endocrinology units
- ENT departments
- ENT medical staff
- Equipment stores
- Gastroenterology departments
- Gastro-intestinal surgeons
- General surgeons
- General surgery
- Gynaecologists
- Haematologists
- Haemodialysis nurses
- Haemodialysis units
- Hospital at home units
- 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
- Minor injury units
- Maternity units
- Maxillofacial departments
- Medical directors
- Medical oncologists
- Medical oncology, directors of
- Midwifery departments
- Midwifery staff
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- NHS walk-in centres
- Obstetricians
- Obstetrics and gynaecology departments
- Obstetrics departments
- Obstetrics nurses
- Oncology nurse specialists
- Orthopaedic surgeons
- Outpatient clinics
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric oncologists
- Paediatric surgeons
- Paediatric surgery, directors of
- Paediatric wards
- Paediatricians
- Paediatrics departments
- Peritoneal dialysis units
- Phlebotomists
- Point of care testing co-ordinators
- Renal medicine departments
- Renal medicine, directors of
- Special care baby units
- Staff supporting patients receiving haemodialysis at home
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urological surgeons
- Urology departments
- Virologists
- Walk-in centres
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practitioners
- General practice managers
- General practice nurses
This Medical Device Alert is being sent to GPs for information only, in circumstances where patients may seek advice about the contents of this notice. GPs need take no further action on receipt of this alert.
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Care homes providing nursing care (adults)
- Clinics
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
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: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/026 or 2019/005/020/291/011
Technical aspects
Anna Biela, MHRA
Tel: 020 3080 6000
Email: DSS-TM@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
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.
Scotland
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
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
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 250986 / 03000 255510
Email: haz-aic@wales.gov
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).
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