MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER 1000CC FLEX ADUENT; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-910C
Medical Device Problem Codes	Use of Device Problem (1670); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer stated liner not creating an adequate suction/practically no suction at all and were collapsing into itself- very little to no suction.Reportedly, the liner doesn¿t completely lose suction, but needed to be rigged with a towel to get suction causing a ten-minute delay.No patient injury and no demographics provided.
Additional Manufacturer Narrative
A review of the manufacturing device history record for lot number j110-314 provided by the customer was performed.The product was manufactured 10-05-21.This investigation determined that all products were manufactured, inspected, and released in accordance with our established specifications for quality and efficacy.Three samples were provided by the customer for review.A visual examination of the returned samples were completed by engineering, production, and quality.The samples did not exhibit any damage or deficiency.The samples were taken to the lab to confirm that the liners would perform as intended in a hard canister.The samples passed.Discussions were held with quality, engineering and production concerning the assignable cause and corrective actions.Based on the information provided, the customer used the wrong hard canister (product code 65652-511).The correct canister to use with flex liners would be any one of the following product codes - 65652-611 , 65652-612 or 65652-616.Using the wrong canister or not using a canister with the liner will cause inadequate or no suction and it will collapse.Based on the investigation, the assignable cause is customer misuse.The customer will be notified on the proper product to use with the flex liners.We will continue to monitor trends and utilize the information as part of continuous improvement.No further action is planned at this time.

• Brand Name: LINER 1000CC FLEX ADUENT
• Common Device Name: 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: 13316024
• Report Number: 1423537-2022-00718
• Device Sequence Number: 11158026
• Product Code: GCX
• UDI-Device Identifier: 50885380029095
• UDI-Public: 50885380029095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

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: 65651-910C
• Device Catalogue Number: 65651-910C
• Device Lot Number: J110-314
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown