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

Model Number 65651-920C

Device Problems Defective Component (2292); Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

No samples, photos or lot number were provided by the customer.Therefore, the device history record could not be reviewed.Discussions were held with engineering, quality and production concerning the assignable cause for the complaint "liner doesn't fit properly into outer canister, liner deflates on itself".With the additional information of "the end user indicates using a flex liner inside a crd canister", the team concluded that the wrong liner was placed in the canister.Based on the information provided, the assignable cause is error on the part of the end user.No corrective action is planned.End user used a flex liner in crd canister.The customer will be provided the correct liner number.

Event Description

Based on information received from the customer, the liner didn't fit properly into outer canister.Reportedly the liner deflates on itself.The customer stated they were able to move forward with the procedure and there was no injury to patient.Follow up conversation with end user indicates incorrect liner may have been used (flex liner inside crd outer canister).

• Brand Name: LINER SUCTION 1500CC
• 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: 10655043
• MDR Text Key: 211847503
• Report Number: 1423537-2020-00541
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 00885380029083
• UDI-Public: 00885380029083
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 65651-920C
• Device Catalogue Number: 65651-920C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other