Tyco Mallinckrodt (Athlone, Ireland) would like to point out that unfortunately, in this instance, the Safety Flex product involved in the complaint was not returned to the manufacturer. Therefore, a comprehensive evaluation could not be conducted relating to potential root cause of this problem.
In the absence of the sample in question, we have attempted to simulate the problem described in the letter by Santos et al. We have been unable to do so under normal simulated use conditions. However, we were able to create an occlusion in a Safety Flex product by subjecting it to sterilization cycles that are different than those used at our manufacturing site. Using a moist heat sterilization cycle or a high-pressure gas cycle, we managed to create occlusions and other disfigurations in the product.
Mallinckrodt manufactures Safety Flex tracheal tubes with defined validated processes, and the product is checked at several key intervals during manufacture to ensure that all quality criteria associated with this product range are met before release of the product from the plant.
We would like to draw the reader's attention to our Instructions for Use leaflet that is supplied with this product. These instructions clearly specify all warnings/precautions to be taken with this product and suggested directions for use.
We regret that the customer experienced problems using one of our products. We do, however, appreciate their bringing this matter to our attention. Feedback is very important because we strive to maintain a high-quality product and a high level of customer communication and satisfaction.
* Tyco Healthcare, Hennef, Germany. firstname.lastname@example.org