During our investigation the lot number was not made available by the customer, therefore, the device history record could not be reviewed.No sample was received; however cardinal health did receive pictures of the customers setup for suctioning, (canister/liner).A team consisting of cardinal health engineering, quality and production reviewed the pictures, we were unable to determine why the liner collapsed from the pictures.Cardinal health, however, received the following statement from the customer, "the problem has been resolved.The issue was on our end.The plastic container had foam tape inside which was causing the liner to malfunction".Based on the information provided, the assignable cause was foam tape inside the canister put there by the customer which prevented a tight seal and the liner collapsed; therefore, no corrective action will be taken at this time.
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From information received from the customer, they reportedly have had issues with the suction liners.The suction liners are collapsing on themselves and forming a loose ball in the suction canisters.When this happens the suction no longer works, and a new liner is needed.Based on information received from the customer during our investigation they stated, ¿the problem has been resolved.The issue was on our end.The plastic container had foam tape inside which was causing the liner to malfunction.¿ based on the customers response there was no injury to staff or patient.
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