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

Model Number	65652-611
Medical Device Problem Codes	Break (1069); Suction Failure (4039)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the canisters are breaking within 4 months of use and that their shelf life is becoming shorter.Canister lost suction on high, low or both and/or cracked at the base and sometimes had decreased suction during unknown procedure.Customer has stated they use clinell wipes to clean them down and leave the canisters on high suctions 24/7 and clamp off the tubing.There was no reported adverse event to patient.No further information was provided by customer.
Additional Manufacturer Narrative
Supplemental report is being filed since the results of investigation are available.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.Photos were sent with the case but are not for the reported product code.Discussions were held with the team from engineering, production, and quality to determine assignable cause and corrective actions for canister that have either lost suction on high, low, or both and/or cracked at the base.The team reviewed the photos that were submitted for the sister complaint as well as the samples from the same sister complaint.It is clearly evident by the smeared and missing print that the hard canisters are being cleaned with contra-indicated cleaners spelled out in the instructions for use.The investigation has also revealed that the hard cans are left on continuous suction 24/7.This practice is contra-indicated by the instructions for use.Solvents attack the areas of highest stress concentration which is around the bottom edge of the canister and at the gate (center of the bottom) making it weak.The continuous high suction will cause the hard canister to break at the weak spots.The combination of contra-indicated cleaners and the continuous high suction will create conditions for canister defects.The instructions for use detail information regarding continuous suction and what type of cleaners to use on the hard canisters, as stated: hardware warnings: 1.Cleaning agents that contain quatemary ammonium salts, strong alkalines or chlorinated benezene (phenols) based hydrocarbons may cause chemical degradation of the material.This could lead to a failure of the products to perform as intended.Warnings: 1.This product is not designed to be kept under vacuum when not in use.Prolonged static vacuum may increase the risk of cracking or implosion.The assignable cause is customer misuse.The damage to the canisters is caused by using contra-indicated cleaners which weaken the polycarbonate followed by continuous high suction 24/7.Trending of past complaint reports indicate that this is the 1st reported incident of canister cracking at bottom for product code 65652-611 in the past three calendar years.

• Brand Name: 1000CC FLEX CANISTER
• 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 ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12872601
• Report Number: 1423537-2021-00691
• Device Sequence Number: 19274070
• Product Code: GCX
• UDI-Device Identifier: 10885380042638
• UDI-Public: 10885380042638
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 65652-611
• Device Catalogue Number: 65652-611
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown