Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0669, written 15 Dec 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 15 Dec 2025 |
|---|---|
| Reference | 2025-0669 |
| Deceased | Anthony Lodge |
| Coroner | Rebecca Sutton |
| Coroner area | County Durham and Darlington |
| Category | Other related deaths |
| Organisation named | County Durham and Darlington NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: REPORT TO PREVENT FUTURE DEATHS NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT DEATHS THIS REPORT IS BEING SENT TO: 1 Managing Director of International Scientific Supplies Ltd 1 CORONER I am Rebecca SUTTON, Assistant Coroner for the coroner area of County Durham and Darlington 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST On 28/07/2025 09:11an investigation was commenced into the death of Anthony Jonathon LODGE 03/08/1974. The investigation concluded at the end of the inquest on 10/12/2025 15:30. The conclusion of the inquest was that On 24 July 2025 at his home address of, , the deceased died as a consequence of a severe urinary tract infection. On 18 July 2025 the deceased had been prescribed antibiotics to treat a suspected urinary tract infection and a urine sample had been taken on the same date to send to the laboratory for testing. Due to the sample container being out of date, it was not possible for the laboratory to process the sample and the deceased died before a further sample was taken. It is unlikely that the out-of-date container contributed to the deceased’s death.. 4 CIRCUMSTANCES OF THE DEATH The cause of death was a severe urinary tract infection. 5 CORONER’S CONCERNS During the course of the investigation my inquiries revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: (brief summary of matters of concern) I heard evidence that the red-topped urine sample bottles containing boric acid (for preservation of the urine) used by the County Durham and Darlington NHS Foundation Trust district nursing team were not stamped with an expiry date, making it impossible for the district nursing team to know whether or not they were using an out of date sample bottle. The laboratory were unable to process the urine sample in this case because the red top sample bottle was out of date. Although it appears that the resulting delay in this case probably did not contribute to the deceased's death, I am concerned that there may be cases in the future where the delay caused by the use of an an out of date specimen bottle could cause or contribute to death. I understand that your company is the manufacturer of the urine specimen bottles used by the district nursing team. 6 ACTION SHOULD BE TAKEN Regulation 28 – After Inquest Document Template Updated 30/07/2021 In my opinion action should be taken to prevent future deaths and I believe you (and/or your organisation) have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by February 09, 2026. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. COPIES and PUBLICATION 8 I have sent a copy of my report to the Chief Coroner and to the following Interested Persons I have also sent it to CDDFT Legal Services who may find it useful or of interest. I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response about the release or the publication of your response by the Chief Coroner. 9 Dated: 15/12/2025 Rebecca SUTTON Assistant Coroner for County Durham and Darlington Regulation 28 – After Inquest Document Template Updated 30/07/2021
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
International Scientific Supplies Ltd
Unit 6
Valley Road
Bradford
West Yorkshire
BD1 4RU
United Kingdom
Thank you for your Regulation 28 report concerning the late Mr Anthony Jonathan Lodge and the use
of red-topped urine sample bottles containing boric acid supplied by International Scientific Supplies
Ltd (ISS).
International Scientific Supplies Ltd (ISS) wishes first to acknowledge the seriousness of the concerns
raised in the Regulation 28 report following the death of Mr Anthony Jonathan Lodge and thanks the
Court for the opportunity to respond.
ISS manufactures and labels its urine specimen containers in accordance with all applicable UK
regulatory and quality requirements for this type of medical container, including those relating to
stability, expiry dating, batch control and packaging information. For the product range used by the
County Durham and Darlington NHS Foundation Trust district nursing team, the expiry date and batch
number are printed on the outer packaging (box) in line with recognised practice for small containers,
and the containers are released only within their approved shelf life under our quality‑management
system. The 10 ml primary tubes are of limited size and are therefore not designed to carry the full
set of outer‑pack details; however, they are traceable to the labelled outer carton under our
established manufacturing and distribution processes. On that basis, ISS is confident that the product,
as supplied, complied fully with our regulatory and compliance obligations at the time of manufacture
and supply.
Following notification of this case, ISS requested confirmation of the specific product code and the lot
(batch) number of the container in question, in order to verify the manufacturing and expiry details of
the exact batch allegedly used. We understand that the Trust has been unable to provide either a
product code or a lot number, so it has not been possible to perform a batch‑specific review of the
individual container referred to in the report. Notwithstanding this, ISS’s internal records and controls
give us confidence that, when supplied to the Trust, the relevant batches were released within their
assigned shelf life, with expiry dating clearly indicated on the associated outer packaging.
ISS notes the Coroner’s conclusion that it is unlikely that the out‑of‑date container contributed to Mr
Lodge’s death. We also note the concern that, in other cases, delay arising from the use of an
out‑of‑date container could contribute to a death and that action should be considered to reduce such
risk.
Within the scope of a manufacturer’s responsibilities, ISS addresses this risk primarily by:
• Ensuring that stability studies, assigned shelf lives and expiry dates are scientifically
justified and appropriately controlled.
International Scientific Supplies Limited
Tel: 01274 720070 Fax: 01274 728295
Email: sales@intscientific.com Web: www.intscientific.com
Company Registered No. 4373041 • VAT Reg No. GB790146918
Certificate No 178395
International Scientific Supplies Ltd
Unit 6
Valley Road
Bradford
West Yorkshire
BD1 4RU
United Kingdom
• Ensuring that expiry dates and batch numbers are applied and legible on packaging,
and that product is not released beyond its approved shelf life.
ISS is satisfied that, for the product range concerned, these controls were in place and that the
labelling and release of the product were compliant with the applicable regulatory and quality
requirements at the time of manufacture and supply.
In summary:
• The urine specimen containers concerned were manufactured, tested, labelled and
released in full compliance with applicable regulatory and quality requirements for this
type of product.
• Expiry date and batch information were applied to the outer packaging in accordance
with established practice for small containers, and product was not released beyond
its approved shelf life.
• Although the Trust has been unable to provide the product code or lot number for the
specific container, ISS’s records and controls support the conclusion that the container,
as supplied, would not have been expired.
ISS remains committed to maintaining robust quality‑management and regulatory‑compliance
systems and to cooperating with healthcare providers and the Court to support patient safety.
Signed on behalf of the Supplier:
Managing Director
International Scientific Supplies Limited
Tel: 01274 720070 Fax: 01274 728295
Email: sales@intscientific.com Web: www.intscientific.com
Company Registered No. 4373041 • VAT Reg No. GB790146918
Certificate No 178395
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