Customer reported physicians are having issues with the drain that is attached to a trocar, passing through the skin.The drain is stiff and hard to strip.Drainage is then low; the drain is removed, and seromas develop.An attempt to drain the seroma is not always successful.The plastics group recently had an infection.Seromas affect the adherence of dermal tissue and the physical appearance of the reconstructive surgery.No additional information or patient demographics provided.
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Based on the supplier investigation, device history record (dhr) could not be reviewed as lot number was not provided.However, supplier had reviewed dhrs for the last five months.They found no abnormality during production and inspection for this product.No sample was available at the time of investigation.Supplier tested their retained samples from two lot numbers produced over the last five months (n210460 and n210468).Their tests included sharpness test, patency test, and drain measurements.The test results meet the products specifications.According to the complaint information that the patient had a seroma during the operation.Supplier had consulted with their medical consultant on this issue.However, there are many causes for a seroma.Based the information provided by customer, it is hard to determine the root cause for this seroma.Based on investigation, the supplier concluded that their products meet the product specification, and they cannot find the root cause of this complaint.There is no action taken at this time.Cardinal health will continue to monitor complaint trends.
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