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	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, the device history record could not be reviewed as a lot number was not provided.A sample was not available for investigation.Photos of the sample were received and reviewed by engineering, quality and production.The team was in consensus that the damage to the bottom of the canisters is due to the contraindicated use of continuous suction for many consecutive days, as well as using inappropriate cleaning and disinfectant agents.Harsh chemicals and continuous suctions are described by the ifu as inappropriate use.The customer has been repeatedly provided advice and training, as well as formal letters from cardinal health after previous product complaints that note these potential sources of misuse.The root 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 ifu.No further action is planned at this time.Continued misuse by the customer.Customer is aware of misuse and refuses to follow warnings from ifu.
Event or Problem Description
Customer reported the canister suction 1500cc flex 65652-616 are cracking along the bottom which reduces the suction of the container when in use.Customer has used dressing tape to repair.Customer confirms they keep the suction on continuously for consecutive days.No clinical data or patient demographics (height, weight, sex, age) were provided after numerous attempts made to obtain.Report being filed for malfunction.

• 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: 10856206
• Report Number: 1423537-2020-00561
• Device Sequence Number: 3284651
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1