Supplemental report is being filed following the submission of the initial mdr report submitted on 4/25/2022 due to the investigation results are available.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.A sample was not provided for evaluation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.We are unable to determine a specific assignable cause for the reported incident.If the canister had a crack before applying suction, this would prevent the unit from functioning as intended.Per the directions for use included with the product, canisters, lids, and components should be inspected for damage from shipping, storage, or handling prior to use.We will continue to monitor trends for this product.
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