Unomedical high concentration oxygen masks (specific lots) - risk of hypoxia as the tubing can disconnect from the oxygen mask

Manufactured by ConvaTec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (MDA/2017/019)

Action

  • Identify and stop using affected devices (see below).
  • Quarantine all affected devices in stock.
  • Contact ConvaTec to acknowledge receipt of the Field Safety Notice (dated 10 May 2017) even if you don’t have affected devices left in stock
  • For any product replacements required, see Field Safety Notice for further details

Action by

All healthcare professionals involved in the use of these devices.

Deadlines for actions

Actions underway: 17 July 2017

Actions complete: 31 July 2017

Device details

The following model (REF number) and LOT numbers are affected:

Product Code / REF No. SAP Code Description LOT No’s. NHS Supply Chain Codes (NPC) FDD
104MM 1302097 Rebreathing mask, Reservoir bag, with Tubing 105631  
106MM 1702436 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7’) Oxygen Tubing 100733, 104106, 104798, 100721, 109824 763
108-E 1300168 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 102766, 102785, 102726, 102352, 105451, 109186  
108MM 1705302 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558 2747
3226-E 1308753 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 102727  
3226MM 1307553 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 100720, 101141  
3230MM 1302405 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 104906, 105181 766
9108MM 1267152 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453  

Manufacturer contacts

Rebecca Evans
ConvaTec Limited

Telephone: 01244 284896

<rebecca.evans@convatec.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 SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • A&E departments
  • Adult intensive care units
  • All staff
  • All wards
  • Ambulance services directors
  • Ambulance staff
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • Biomedical engineering staff
  • Cardiology departments
  • Community hospitals
  • Day surgery units
  • EBME departments
  • ENT departments
  • Equipment stores
  • Equipment libraries and stores
  • General surgery
  • Health and safety managers
  • Hospital at home units
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (adult)
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • NHS walk-in centres
  • Paediatric intensive care units
  • Paediatric wards
  • Paediatrics departments
  • Paramedics
  • Patient transport managers
  • Purchasing managers
  • Risk managers
  • Supplies managers
  • Theatres
  • Theatre practitioners

NHS England area teams

CAS liaison officers for onward distribution to all relevant staff including:

  • General practitioners

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Independent treatment centres

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 Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2017/019 or 2017/005/009/701/010.

Technical aspects

Suleman Hussain or Enitan Taiwo, MHRA

Tel: 020 3080 6956 or 020 3080 7122

Email: suleman.hussain@mhra.gov.uk or enitan.taiwo@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

Please report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland

Tel: 0131 275 7575

Fax: 0131 314 0722

Email: nss.iric@nhs.net

Reporting adverse incidents in Scotland

NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.

Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division,
Welsh Government

Tel: 02920 823 624 / 02920 825 510

Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2017/019 - Unomedical high concentration oxygen masks (specific lots)

Published 10 July 2017