SmartTap Paracentesis Drainage Tray w/9cm Catheter

DOCUMENT NO.: RD-001R27W, REV. 01 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-0020T
Product Description: SmartTap Paracentesis Drainage Tray w/9cm Catheter
Product Quantity: ______________________
(to be filled out by Nipro Canada Quality Assurance)
Product Lot Number: ______________________
(to be filled out by Nipro Canada Quality Assurance)

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. Is the volume of the drainage bag adequate for the procedure?
6. Does the tubing and stopcock provide suitable drainage flow for timely treatment?
The responses to this survey will be used for research and regulatory purposes only.