14.5F x 28cm HighFlow™ I.R. Dialysis Catheter Kit

QUALITY RECORD: DESIGN VALIDATION SURVEY

As part of our desire to serve you better and to address Health Canada regulatory requirements, we would appreciate your feedback on this product. After performing the product evaluation on the samples provided, please complete the survey below.
Evaluation Description: To confirm that the product meets user requirements when it is used for its intended purpose.
Product code: CM-28HFIRV
Product Evaluation Quantity: 10
Product Evaluation Lot Number: 032329
Hospital/Clinic Centre: Lakeridge Health Oshawa

Questions

1. Does the product perform as intended?
2. Does this product contain all the materials required to complete the procedure functionally and safely?
3. Does the document titled 'Instructions for Use' provide clear and concise directions?
4. Is the packaging and labeling suitable for this product?
5. Are the tunneller, guidewire, and introducer suitable for the procedure?
6. Is the size of the triplicate patient label acceptable for use?
7. Are the catheter and its placement components adequately visible under medical imaging?
The responses to this survey will be used for research and regulatory purposes only.

DOCUMENT NO.: RD-001R27, REV. 03