MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER SUCTION 1500CC; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number 65651-920C

Device Problems Collapse (1099); Improper or Incorrect Procedure or Method (2017); Suction Failure (4039)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

During our investigation the lot number was not made available by the customer, therefore, the device history record could not be reviewed.No sample was received; however cardinal health did receive pictures of the customers setup for suctioning, (canister/liner).A team consisting of cardinal health engineering, quality and production reviewed the pictures, we were unable to determine why the liner collapsed from the pictures.Cardinal health, however, received the following statement from the customer, "the problem has been resolved.The issue was on our end.The plastic container had foam tape inside which was causing the liner to malfunction".Based on the information provided, the assignable cause was foam tape inside the canister put there by the customer which prevented a tight seal and the liner collapsed; therefore, no corrective action will be taken at this time.

Event Description

From information received from the customer, they reportedly have had issues with the suction liners.The suction liners are collapsing on themselves and forming a loose ball in the suction canisters.When this happens the suction no longer works, and a new liner is needed.Based on information received from the customer during our investigation they stated, ¿the problem has been resolved.The issue was on our end.The plastic container had foam tape inside which was causing the liner to malfunction.¿ based on the customers response there was no injury to staff or patient.

• Brand Name: LINER SUCTION 1500CC
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• 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: 11298582
• MDR Text Key: 232150564
• Report Number: 1423537-2021-00590
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 50885380029088
• UDI-Public: 50885380029088
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other