MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER SUCTION 1500CC; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	65651-920C
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: LINER SUCTION 1500CC
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 11298582
• Report Number: 1423537-2021-00590
• Device Sequence Number: 11040856
• Product Code: GCX
• UDI-Device Identifier: 50885380029088
• UDI-Public: 50885380029088
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 65651-920C
• Device Catalogue Number: 65651-920C
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other