MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER CANNSTR SUCT 1500CC DISP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-515
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided by the customer; therefore, a review of the manufacturing device history record could not be performed.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Based on the investigation, no specific assignable cause can be determined as there is limited information.We are unable to determine if the lid or liner had deficiency due to the molding process or the issue was at the end user.Without a specific assignable cause, no action will be taken at this time.We will continue to monitor trends based on this type of issue.
Event or Problem Description
Customer reported that when the suction canister was replaced during an emergency c-section, it had no suction and the liner was being crushed within the hard shell as if the vacuum pressure was suctioning around the liner instead of within the liner.There was a 5-7 minute delay to change out to a new canister with no adverse event or injury to the patient.

• Brand Name: LINER CANNSTR SUCT 1500CC DISP
• 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: 13726469
• Report Number: 1423537-2022-00733
• Device Sequence Number: 5678630
• Product Code: GCX
• UDI-Device Identifier: 50630140152656
• UDI-Public: 50630140152656
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: 65651-515
• Device Catalogue Number: 65651-515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 86 KG