PFD report

Anthony Jonathon LODGE · Prevention of Future Deaths report

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Issued 15 Dec 2025•County Durham and Darlington

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
4

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised1

  1. Lack of expiry dates on urine specimen bottles
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. Action

    Control scientifically justified stability studies, assigned shelf lives and expiry dates for urine specimen containers.

    Stated by International Scientific Supplies LimitedStated completedThe respondent said that this action was complete when they made their response on 19 December 2025.
  2. Action

    Apply legible expiry dates and batch numbers to packaging and prevent release of products beyond approved shelf life.

    Stated by International Scientific Supplies LimitedStated completedThe respondent said that this action was complete when they made their response on 19 December 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    Existing stability, expiry-control, labelling and release processes were considered sufficient to manage the risk of expired urine specimen containers.

    Stated by International Scientific Supplies LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Lack of expiry dates on urine specimen bottles

Wider context from the report

“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 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. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Control scientifically justified stability studies, assigned shelf lives and expiry dates for urine specimen containers.

Verbatim wording from the response

“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.”

Source location

Response from International Scientific Supplies Ltd
Page 1 · response
Published 19 December 2025

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Apply legible expiry dates and batch numbers to packaging and prevent release of products beyond approved shelf life.

Verbatim wording from the response

“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.”

Source location

Response from International Scientific Supplies Ltd
Page 1 · response
Published 19 December 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing stability, expiry-control, labelling and release processes were considered sufficient to manage the risk of expired urine specimen containers.

Verbatim wording from the response

“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.”

Source location

Response from International Scientific Supplies Ltd
Page 2 · response
Published 19 December 2025

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. 1

    Continue cooperating with healthcare providers and the Court to support patient safety.

    Stated by International Scientific Supplies LimitedStated in progressThe respondent said that this action was in progress when they made their response on 19 December 2025.
  2. 2

    Maintain robust quality-management and regulatory-compliance systems supporting patient safety.

    Stated by International Scientific Supplies LimitedStated in progressThe respondent said that this action was in progress when they made their response on 19 December 2025.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The supplied container would not have been expired, contrary to the concern that an out-of-date container may have contributed to delay or death.

    Stated by International Scientific Supplies LimitedDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue cooperating with healthcare providers and the Court to support patient safety.

Verbatim wording from the response

“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.”

Source location

Response from International Scientific Supplies Ltd
Page 2 · response
Published 19 December 2025

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Maintain robust quality-management and regulatory-compliance systems supporting patient safety.

Verbatim wording from the response

“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.”

Source location

Response from International Scientific Supplies Ltd
Page 2 · response
Published 19 December 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The supplied container would not have been expired, contrary to the concern that an out-of-date container may have contributed to delay or death.

Verbatim wording from the response

“• 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.”

Source location

Response from International Scientific Supplies Ltd
Page 2 · response
Published 19 December 2025

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026