Patient Safety Incidents and Product Complaints
Product Complaint Documentation can lead to safer patient care
Product complaint reports notify the vendor about a problem we’ve experienced or identified. It is a formal process to communicate and engage the vendor in responding or investigating the reported issue.
The RL Patient Safety Reporting system will now be used to summarize and initiate the product complaint process. Paper product complaints have been discontinued except for drug complaints and service contract or vendor representative concerns.
Please submit any concerns with equipment such as large volume pumps and supplies using RL. The online form for Provincial Large Volume Pump Complaints has been discontinued.
Additional resources for using RL can be found on the RL Event Reporting page. The purpose of this page is to focus on how to Document and Manage Equipment or Supplies that contributed to a patient safety event.
Supply and Equipment Reminder
Equipment involved in safety events will also need to be assessed by a Technical Service Team member to ensure it is in proper working order so other similar patient safety events can be avoided. Technical Service Team members include Clinical Engineering, BioMedical, Medical Physics/Nuclear Electronics and Facility/Maintenance team members.
Please see the outline of how to package up IV tubing for sending to material management/delegated department.
Frequently Asked Questions
Reporting and Documenting
What is Vanessa’s Law?
Vanessa was a young Canadian who died after taking a prescribed medication for a stomach problem. The U.S. had already warned against using this drug for similar conditions, but Health Canada did not yet have enough information to act.
Her father pushed for stronger reporting rules in Canada, which led to Vanessa’s Law. This Federal legislation is also called Protecting Canadians from Unsafe Drugs Act.
Vanessa’s Law requires hospitals to report serious drug reactions and medical device incidents to Health Canada within 30 days. This helps Health Canada identify problems sooner and decide whether actions like recalls or corrections are needed.
Why is it important to report on equipment and product concerns?
Problems with medications and medical devices can happen at any time. If we don’t report these issues, action cannot be taken, and Vendors and Health Canada will not know there is a problem.
When you report concerns in RL, you are alerting the right teams about the issue and its seriousness. This helps us track trends across the province, understand the risks, and decide how to support safe clinical care.
What are Medical Devices?
Medical devices are regulated by Health Canada and include many types of equipment and supplies used in health care. They range from simple items like wound care supplies to complex tools used in procedures or surgery.
What is changing in RL?
Patient Safety incident reports and product complaints serve different purposes, and RL now captures all the key questions and required information for reporting.
- Patient safety incident reports help us document issues inside our organization. We review them to improve our processes and reduce risks in the care we provide.
- Product complaint reports notify the vendor about a problem. This formal process is needed because vendors are not required to act unless we report the issue.
Paper product complaints will be discontinued except for drug product complaints, service contracts and vendor representative concerns.
What are the changes to the Equipment and Supply Involved tables?
If your site is supported by Clinical Engineering/Biomedical or Supply Chain/Materials Management, you can search for the equipment or supplies in the RL tables. This will automatically fill in the key details.
If your site manages its own equipment or buys supplies independently, manually enter the information such as serial number or unique identifying numbers.
To search and fill in the required details for the vendor and Health Canada reporting:
- Click on Add in the Equipment Involved or Supply Involved section
- Click the magnifying glass to open the search box.
- Enter the Asset Tag/Equipment ID for an equipment search
- Enter the Product Code from the packaging for a supply search.
For more details, see the RL – Medical Device Incident (MDI) Reporting QRG on our RL Event Reporting page.
How to report a Near Miss/Good Catch for equipment or supply concerns
A near miss or good catch is an incident where you spot a risk and address it before it reaches the patient. In RL, you can report this by selecting “Near Miss/Good Catch” under the Severity Level section of the event form.
If a near miss or good catch does not match a specific event category – such as risk for fall, medication error, or delay in treatment – you can document the near miss under the Facilities/Equipment/Environment form and selecting the General Equipment/Supply Issue event type.
What is the purpose of a product complaint?
A product complaint is a formal way to tell a vendor about a concern with their product through the supply chain process. This requires the vendor to investigate the issue.
If Health Canada is involved, the vendor must also report back to them. This process helps identify problems that may not already be known and can lead to recalls or safety alerts. Without a formal complaint, the vendor is not required to act.
What do I do if I don’t have time to report?
We recommend you talk with your manager or supervisor if time is limited and you are unable to complete health record documentation and report of the incident or concern, so they can help with problem-solving.
What will you do with the supply information submitted in RL?
Supply Chain uses RL information to create and submit a formal product complaint to the vendor, along with any evidence.
The vendor investigates and sends a report back to Supply Chain, and to Health Canada if required.
This process helps vendors find issues that were not identified before the product was released and can lead to recalls or safety alerts. Including details such as the impact on the patient and actions taken helps Health Canada monitor trends and take action when needed.
Managing Defective Supplies and Equipment
Why do I have to keep the products and packaging involved in incidents?
You need to keep the product and its packaging because they are evidence. Vendors and Supply Chain may need to examine them to understand what went wrong.
If Health Canada becomes involved, they may ask the vendor to do more testing.
Why are defective supplies considered biohazardous?
Once a product reaches a clinical area/patient environment, there is a risk it has come into contact with contaminants. Because it is difficult to prove that the item remained uncontaminated after being removed from its original packaging, we must treat it as a biohazardous material.
Transportation regulations require that items with potential exposure to biological contaminants be handled, packaged, and shipped according to specific legal standards. These rules ensure the safety of everyone involved in handling the product during transport.
What happens if I can’t keep the product?
If you can’t keep the item or packaging, save as much information as possible, such as:
- Product code or vendor number
- Lot or batch number
- Expiry date
- Photos of the product if permitted with your program’s policies.
This information still helps Supply Chain, the vendor, and Health Canada understand the issue, even if the actual product is no longer available.
I work in the community, what do I do with a supply issue?
When an issue or concern with a supply occurs in the community, the supply cannot be transported by you to a facility or office space, because you are not certified to transport biohazardous materials (i.e., materials that have been in contact with the client’s environment).
Instead, document the details and report the incident following your established procedures. See the question “What happens if I can’t keep the product?” for more information.
How can I know the lot number if we throw out the packaging?
Lot numbers show when and where a product was made. They are important for tracking problems and identifying recalls. Without the lot number, it can be harder for vendors or Health Canada to confirm product issues.
One strategy does not work in all clinical environments. Please brainstorm as a team on ideas and options that could work to find and document lot numbers for products/supplies involved in patient safety incidents or near misses/good catches.
What do I do if equipment (like a pump) is involved in a patient safety incident?
If you believe equipment has failed or malfunctioned and contributed to an event:
- Remove the equipment from use right away.
Secure or isolate it so no one uses it again until we know it is safe and working properly. - Follow your site’s process for tagging equipment.
- Attach a “Do Not Use” tag. Note – there are different tags used across the Province to communicate the equipment is out of service and should not be used to provide care.
- Include the RL file number on the tag.
- Send the equipment to the correct department (Clinical Engineering/Biomed, Facilities/Maintenance or Medical Physics/Nuclear Electronics) for assessment
What are the criteria for reporting a Medical Device Incident (MDI)?
Individuals reporting and reviewing safety incidents involving a medical device should consider the following:
- Equipment failure (based on information available)
- Any deterioration of the equipment’s effectiveness
- Unclear, inadequate labelling or directions that led to patient death or serious harm, or could led to death or serious harm if an incident were to reoccur
- Complaint trends
- Potential to lead to death or serious deterioration in health of a patient, user, or other person
Tip – include the patient safety incident number on the “Do Not Use” tag so Technical Service Team members can follow up with any missing details.
What should I document in a patient safety incident involving an MDI?
In the Additional Information section, please document the following:
- Facts or a description of what happened, including any alarm messaging
- What actions were taken to care for the patient, including if additional interventions were required
- Impact to patient or risk to patient if a similar incident were to occur
- Anything that you think made the incident more likely to happen, such as patient medical conditions, access to equipment/supplies, etc.
When should I include both equipment and supply details?
Include both equipment and supply details when you’re not sure which one contributed to the incident.
For example, in an event involving an IV pump and tubing, if usual troubleshooting steps—checking IV patency, flushing the line, confirming the clamp is open, and verifying bag height—do not fix upstream or downstream alarms, then both the pump and the tubing may be involved.
Providing details for each component helps with the investigation. When in doubt, always include both so that all possible causes can be assessed.