MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANISTER 1200CC GUARDIAN; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 65651-212

Device Problems Break (1069); Suction Failure (4039)

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

Event Date 01/01/1980

Event Type  malfunction  

Event Description

Customer reported they received two cases of suction canisters where the boxes were damaged upon breaking down their pallet.They were not noticed as the boxes were in the middle.The product looked usable but on multiple occasions they stopped working mid procedure during various planned gastrointestinal procedures.There was a 1-2 minute delay to switch out the canisters.Event date is unknown.No demographics were provided.No injury to patient.Patient reported doing fine.

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Manufacturer Narrative

Supplemental report is being filed following the submission of the initial mdr report submitted on 4/25/2022 due to the investigation results are available.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.A sample was not provided for evaluation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.We are unable to determine a specific assignable cause for the reported incident.If the canister had a crack before applying suction, this would prevent the unit from functioning as intended.Per the directions for use included with the product, canisters, lids, and components should be inspected for damage from shipping, storage, or handling prior to use.We will continue to monitor trends for this product.

• Brand Name: CANISTER 1200CC GUARDIAN
• 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: 14197494
• MDR Text Key: 299153384
• Report Number: 1423537-2022-00759
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 50630140152533
• UDI-Public: 50630140152533
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 65651-212
• Device Catalogue Number: 65651-212
• Device Lot Number: J112-046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1