MAUDE Adverse Event Report: DeRoyal Industries, Inc. Disposable Exudate Canister, 450 ml w/Solidifier and Tubing; BOTTLE, COLLECTION, VACUUM

Model Number	NP-0450
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "i would like to report a product complaint regarding multiple 450cc canisters x 2 where the tubing has become detached from the canister.Staff was able to replace the canister, however, this costs time and money due to replacing the canister." deroyal industries, inc.Requested return of the device, however, it was stated as unavailable for return.The device history record (dhr) was reviewed for the lot provided and no issues were found.An inventory check was performed on a different device that is manufactured in the same way and no issues were found.Engineering came to do some testing in may of 2026 when this issue first occurred.They did observe intermittent issues: the light in the curing station did not always activate when the switch was pressed, and the power supply beeped.The light head was positioned 3/8" from the part, and it was then adjusted to be as close possible.They recommended to the place the light sources and add a uv intensity meter to verify output.Keep checking the bond strength with the current method of pulling on the tubing after curing.From this, engineering believes the most likely explanation for the bonding issue is light malfunction.Secondary causes could be reduced light output, increased distance of light from part.A complaint to sales ratio was conducted from may 2024 to present and found to be (b)(4) root cause: based on investigation from engineering and production records, the most likely explanation for the bonding issue is light malfunction.Secondary causes could be reduced light output, increased distance of light from part.Corrective and preventive action: a corrective and preventive action point was opened to address this issue.Revalidation will done on the gluing and curing process.Deroyal will continue to monitor for issues around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: Disposable Exudate Canister, 450 ml w/Solidifier and Tubing
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DeRoyal Industries, Inc.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DeRoyal Industries, Inc.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; +1(865)362-2106
• MDR Report Key: 50846105
• Report Number: 2320762-2026-00025
• Device Sequence Number: 21319458
• Product Code: KDQ
• UDI-Device Identifier: 50749756908189
• UDI-Public: 50749756908189
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: NP-0450
• Device Lot Number: 63315421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown