Field Safety Notices (FSNs): 15/07/24 – 19/07/24

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

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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

1.    Product Recall: Priya & Peanut Sensory Cloud Ribbons (2406-0095)

Section 2: medical devices 15/07/24 – 19/07/24

1. werfen: NOVACLONE™ Anti-D IgM + IgG Monoclonal Blend 15th July 2024 Anti-Rh(D) red blood cell grouping IVD, antibody MHRA reference: 31214989 
2. Exmoor: Aural Ventilation Tubes 15th July 2024 Model: E104 Shepards Drain without wire 0.97 mm E106 Collar Button 1.14 mm MHRA reference: 31218724 
3. Boston Scientific: WAVEWRITER ALPHA IPG KIT-WAVEWRITERALPHA 16IPG KIT 17th July 2024 please refer to section 8 Model: SC-1216 and SC-1232 MHRA reference: 31234955 
4. Andersen Caledonia: SP Eye Sharps Safe Intravitreal Injection Needle 16th July 2024 MHRA reference: 31235759 
5. Exmoor: Silicone Sheets, Discs and Strips 15th July 2024 Surgical anti-adhesion material, nonimplantable E201 E202 E204 SRS1 SRS1A MHRA reference: 31237622 
6. Bruker: UMIC Colistin 11th July 2024 Antibacterial minimum inhibitory concentration IVD MHRA reference: 31190956  
7. QuidelOrtho: VITROS XT Chemistry Products ALB-TP Slides 10th July 2024 Multiple-type clinical chem analyte IVD, reagent MHRA reference: 31215093    MHRA reference: 31215093 
8. INNOMED, INC: Cup Removal Starter Instrument-54MM 17th July 2024 5200-54 MHRA reference: 31233671 
9. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 12th July 2024 Chemiluminescent Immunoassay analyser IVD C11137 MHRA reference: 31234326   MHRA reference: 31234326 
10. Change Healthcare: Change Healthcare Cardiology 45474 Information system, cardiology 14.0, 14.1.1,14.2 ,14.3, 14.3.2, 15.0.1 MHRA reference: 31190985….

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. 

Section 3: updates and changes to previously published medical device FSNs

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 7

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