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

Model Number 65651-930C

Device Problems Collapse (1099); Suction Failure (4039); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2020

Event Type  malfunction  

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 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
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10828539
• MDR Text Key: 217633848
• Report Number: 1423537-2020-00559
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00885380028949
• UDI-Public: 00885380028949
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 65651-930C
• Device Catalogue Number: 65651-930C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR