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Manufacturers’ Field Safety Notices
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This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.
This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.
You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.
Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).
Section 1: estates, facilities or general products
None
Section 2: medical devices 17/07/23 -25/07/23
- BD: Alaris Gateway Workstation 45110 Infusion pump management unit, mobile MHRA reference: 5386355
- Cook Medical: Lead Clippers 45127 General-purpose surgical scissors, single-use MHRA reference: 5363510
- Getinge: APERLAN PY AGENT A, APERLAN PY AGENT B CAPA 850904 Disinfectant, medical device Model: APERLAN PY AGENT A, APERLAN PY AGENT B MHRA reference: 5387929
- LeMaitre: Chevalier Valvulotome 45120 Valvulotome MHRA reference: 5383845
- Mercian Surgical Supply: Universal Scissors 18cm With Black Handles FSCA ref 259 MHRA reference: 5386114
- MicroVention: Flow Re-Direction Endoluminal Device (FRED™) 45103 Stent, Vascular, Intracranial MHRA reference number: 5365238
- NIDEK: EyeCee ONE Crystal preloaded etc 45120 Posterior-chamber intraocular lens, pseudophakic Model: < Add model (normal style)> MHRA reference: 5385301
- Philips: Allura Xper and Azurion Systems 45100 Interventional Fluoroscopic X-Ray System MHRA reference: 5384036
- Quotient: ORTHO Sera Anti – Lea 45117 Anti-Lea red blood cell grouping IVD, antibody Model: FD212B MHRA reference: 5364901
- Siemens Healthineers: Atellica CH 930 Analyzer 44958 MHRA reference: 5384186
- W.O.M.: Aquilex Fluid Control System 45124 Hysteroscopic irrigation/insufflation system Model: AQL-100PBS and AQL-100P MHRA reference: 5384433
- Wyvern Medical: Saliveze and Moi-Stik 45098 Model: 50ml MHRA reference: 5361170
- Xiros: CC-Hook 45071 Suture/Needle Passer Model: 202-1413 & 202-1411 MHRA reference: 5384080
The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here.
Adverse Incidents
Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
- In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
- Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
- Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
- Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/
Incident Reporting & Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts
We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more about our services at www.nss.nhs.scot
FAC406-015, 8B(i), Rev 6