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

Model Number	65652-616
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product lot number not available.The device history record could not be reviewed.No sample was received at the (b)(4) facility.Photos were received and reviewed.A team from engineering, quality, and production reviewed the photos.The team was in consensus that the damage to the bottom of the canisters is due to the contraindicated use of harsh chemicals to clean the canister.Additional information from the customer was received and reviewed, as well.The customer uses continuous suction for many consecutive days, as well as using disinfectants that are contraindicated by the information for use (ifu).The customer has been repeatedly provided advice and training.The customer has also received formal letters from cardinal after previous product complaints that note these potential sources of user misuse.The assignable cause is due to the product being used incorrectly.The cracks in the canister are due to continuous suction and harsh chemicals used to clean the canister, both of which are noted as product misuse against the information for use (ifu).The customer will be provided the information for use for this product.No further action is planned at this time.
Event or Problem Description
Based on information from the customer, allegedly the canister is not keeping suction on continuously.There is reportedly a crack in the bottom of container.Reportedly it reduces the suction of the canister when in use.

• Brand Name: CANNISTER SUCTION 1500CC FLEX
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 10701554
• Report Number: 1423537-2020-00552
• Device Sequence Number: 1138027
• Product Code: GCX
• UDI-Device Identifier: 10630140153860
• UDI-Public: 10630140153860
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 65652-616
• Device Catalogue Number: 65652-616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other