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List of FSNs covering the period 06 to 10 Nov, published by MHRA on 17 November and circulated by IRIC on 17 November
Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
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
2. Product Safety Report: Five models of Heavy Duty Floor Crane sold via Amazon (2304-0071)
Section 2: medical devices 06/11/23-10/11/23
- Arthrex: FiberTape Cerclage Disposable Tensioner 45232 Suturing needle, single-use Model: AR-7820 MHRA reference: 27550955
- B Braun: SeQuent Please NEO 45238 Coronary angioplasty balloon catheter, drug-coated Model: 1) 3.5×25 mm, 2) 3.5×30 mm MHRA reference: 27548863
- BD: Alaris Pump Sets, Gravity, and Extension infusion sets 45211 MHRA reference: 27541095
- Cook Medical: Quantum TTC Biliary Balloon Dilator 45233 Gastrointestinal/biliary dilation balloon catheter MHRA reference: 27541040
- E & O Laboratories Ltd: Saline (0.85%) with Beads 45238 Model: BM0385 MHRA reference: 27547173
- FEATHER SAFETY RAZOR CO., LTD: Standard Incision Scalpel 45196 Ophthalmic knife, single-use Model: 200200700, 200200715, 200200722, 200200730, 200200745 P-700 (200200700), P-715 (200200715), P-722 (200200722), P-730 (200200730), and P-745 (200200745) MHRA reference: 27447049
- Integra: Codman Cranial Hand Drill 45016 Manual Cranial Rotary Handpiece Single-Use MHRA reference: 27537264
- JRI Orthopaedics: SECURUS Revision Stem System 45237 Orthopaedic bone screw, non-bioadsorbable Model: SECURUS Distal Locking Screw 30mm MHRA reference: 27541087
- KARL STORZ: FIVE S 5.3×65, sterile, for single use 45113 Flexible video intubation laryngoscope Model: 0915612-06 MHRA reference: 27531360
- Medtronic: Cobalt ,Crome + others November 2023 FA1326 P2 MHRA reference: 27527923
- Medtronic: LINQII Insertable Cardiac Monitor November 2023 FA1368 MHRA reference: 27532055
- Philips: Allura Xper, Allura Centron, and Azurion systems 45226 Interventional Fluoroscopic X-Ray System Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 MHRA reference: 27550195
- Philips: MD Eleva systems 45226 Interventional Fluoroscopic X-Ray System Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 MHRA reference: 27550195
- Philips: Allura Xper, Azurion and MultiDiagnost -E 45230 Interventional Fluoroscopic X-Ray System Model: 722002 722012 722025 722035 722065 722221 722228708032 722003 722013 722026 722038 722066 722222 722280708034 722005 722015 722027 722039 722067 722223 722400708036 722006 722019 722028 722058 722068 722224 708037 722008 722020 722029 722059 722078 722225 708038 722010 722022 722031 722063 722079 722226 722001 722011 722023 722033 722064 722134 722227 MHRA reference: 27551001
- Sebbin: Fat Washer 800 45218 MHRA reference: 27483084
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)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
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
FAC406-212, 8B(i), Rev 6
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