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

Model Number 65652-611

Device Problems Break (1069); Crack (1135); Suction Problem (2170); Device Markings/Labelling Problem (2911); Suction Failure (4039)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1980

Event Type  malfunction  

Event 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.

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
• 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 ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12872601
• MDR Text Key: 288137570
• Report Number: 1423537-2021-00691
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10885380042638
• UDI-Public: 10885380042638
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 12/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other