FOI release

Freedom of Information request (FOI 22/1142)

Published 17 January 2024

FOI 22/1142

15th December 2022

Dear

Thank you for enquiry.

In response to this, please see the information in the tables below which shows the number of reports for adverse events submitted in relation to the following as of 01st January 2021 to 05th December 2022 inclusive.

This includes reports received from manufacturers, healthcare professionals and members of the public.

These figures need to be interpreted with caution as they are not the same as complication rates.

Product	Number of incidents on the MHRA database
1.Puraplas	None reported.
2. Dermal Roller (and its variations ‘derma roller’ and ‘dermaroller’)	Less than 5 incidents reported.
3. Peripheral IV Cannulas	350 incidents reported. Please see table below for device problems reported.
4. PDO Threads	Less than 5 incidents reported.

We have received 350 reports for adverse events submitted in relation to peripheral IV cannulas as of 01st January 2021 to 05th December 2022 inclusive. Of these 350 reports, the following device problems were reported:

Device problems reported for Peripheral IV Cannulas	No. of reports
Mechanical problem	187
Material Integrity problem	60
Adverse event without identified device or use problem	30
Manufacturing packaging or shipping problem	26
Infusion or flow problem	22
Insufficient information	6
Contamination/decontamination problem	5
Connection problem	<5
Patient device interaction problem	<5
Activating positioning or separation problem	<5
Output problem	<5
Protective measures problem	<5
Use of device problem	<5

It is important to note that the inclusion of a report on our adverse incident database does not necessarily mean the events described were caused by that device but could be due to unrelated patient/user factors.

The data must be read together with the following explanations:

• The majority of reports indicate an issue experienced by a single user. However, some cases may represent the same user experiencing further issues or multiple events in the same report.
• Reports do not necessarily represent an individual patient. Individuals may report an incident at any time after the event and people can make multiple reports at any time after the use of device and on the same issue. Where possible, multiple reports for the same event are linked. However, as reporters are not required to complete all fields, we cannot always be sure enough to link every duplicate
• It should be noted that this information may include a range of recognised complications related to this type of procedure and does not necessarily indicate a fault with any particular device.
• The numbers may include reports where the incident has been taken from published literature or the report may be about notification of a safety communication.
• These numbers of reports are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter of the incident gives us more details later.

As with all medical devices the MHRA continues to monitor the safety and performance and encourages reporting of any adverse incidents through its Yellow Card scheme on https://yellowcard.mhra.gov.uk/.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division