Field Safety Notices (FSNs): 19/12/22 – 23/12/22

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

1. Product Safety Alert: Baby Self-Feeding Products (PSA4) – for awareness of community midwives and health visitors
2. Urgent Safety Alert issued for baby self-feeding products – for awareness of community midwives and health visitors

Section 2: medical devices 19/12/22 – 23/12/22 (please note no FSNs list has been received from MHRA for w/b 5^th and 12^th December 22)

1     Acumed: Locking Cortical Screw, Non-Locking Hexalobe Screw 44909 Model: COL-3140-S, 30-0303-S MHRA reference: 4632028

3. Acutronic: fabian HFO, +nCPAP evolution, Therapy evolution 44851 Model: 111001, 111001.01, 112001, 113001, 122001, 122012, 121001, 121012 MHRA reference: 4641068
4. Future Diagnostics: STAT-IntraOperative-Intact PTH Immunoassay kit 44900 MHRA reference: 4632022
5. Insulet: Omnipod DASH Personal Diabetes Manager (PDM) 44851 Model: 18239 MHRA reference: 4617868
6. International Medical Industries: Guarded Luer Connector (GLC) 44897 Model: 57-400 / 57-400W / 57-401 / 57-402 / 57-403 MHRA reference: 4629491
7. JRI Orthopaedics: Furlong H-A.C Stem & H-A.C Revision Stem 44907 Model: Furlong H-A.C Femoral Stem 8mm MHRA reference: 4624145
8. LiNA: Librata 44909 Model: LIB-1 MHRA reference: 4632414
9. macopharma: Storage solution for blood platelets SSP+ 44907 Model: SSP+ 250ml (UK) MHRA reference: 4632020
10. Rayner: RayOne EMV 44901 Model: RAO200E MHRA reference: 4595578
11. Richard Wolf: HOOK ELECTRODE MONO 9FR 0° 44904 Model: 868895 MHRA reference: 4617650
12. Siemens Healthineers: IMMULITE 2000 Thryoglobulin 44896 MHRA reference: 4632510
13. Siemens Healthineers: Axiom Luminous TF, Luminous DRF MAX, AXIOM ICONOS R200 C90_C, Luminous DRF, Luminous AGILE, Luminous AGILE MAX, Luminous Lotus MAX Ref UI XP051/22/S MHRA reference: 4632013
14. Surgical Holdings: ARTHRODESIS WIRE 44907 Model: 1.2MM x 100MM LONG TROCAR/TROCAR PACK OF TEN STERILE SINGLES MHRA reference: 4632505
15. Teleflex: RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy; Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy; Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal 44896 MHRA reference: 4641055
16. Zimmer Biomet: NexGen Option Stemmed Tibial Component 44901 MHRA reference: 4643835

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

Contact us:

IRIC Email         nss.iric@nhs.scot

Helpline             0131 275 7575

Web                 https://www.nss.nhs.scot/browse/health-facilities/incidents-and-alerts

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NHS National Services Scotland is the common name for the Common Services Agency for the Scottish Health Service. www.nhsnss.org

FAC406-015, 8B(i), Rev 6