MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER 3000CC FLEX ADVANTAGE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-930C
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample or lot number were received for this investigation.A short video was received of the canister/liner.A team consisting of cardinal health engineering, quality and production was unable to review the device history record as no lot number was received.The video was reviewed and while it is hard to tell why the liner collapsed from the video, it was clear that it collapsed.Based on the information provided, no specific assignable cause can be determined for this case.Therefore, no specific corrective action could be completed.Key production and quality personnel have been made aware of this reported incident through this investigation process.
Event or Problem Description
Based on information received from the customer the disposable flexible liner reportedly collapsed, activated the filter, and did not suction.The liner was discarded.

• Brand Name: LINER 3000CC FLEX ADVANTAGE
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 10828539
• Report Number: 1423537-2020-00559
• Device Sequence Number: 4329508
• Product Code: GCX
• UDI-Device Identifier: 00885380028949
• UDI-Public: 00885380028949
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 65651-930C
• Device Catalogue Number: 65651-930C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR