MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OUTER SHELL CANISTER, 1500CC, BRACKET; BOTTLE, COLLECTION, VACUUM

Model Number	71-1500BR
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributing facility reported, "trial of new product shows product cant be used appropriately.The suction canister tip does not fit into the suction system.During a procedure where quick suctioning needs to be performed, the unit will fail to provide suction and suctioned contents will spill or spray on caregivers, the patient, and the sterile operating/procedure area.".
Additional Manufacturer Narrative
A distributing facility reported, "trial of new product shows product cant be used appropriately.The suction canister tip does not fit into the suction system.During a procedure where quick suctioning needs to be performed, the unit will fail to provide suction and suctioned contents will spill or spray on caregivers, the patient, and the sterile operating/procedure area." deroyal industries, inc.Requested return of the device, however it has not yet been received.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Additional Manufacturer Narrative
A distributing facility reported, "trial of new product shows product cant be used appropriately.The suction canister tip does not fit into the suction system.During a procedure where quick suctioning needs to be performed, the unit will fail to provide suction and suctioned contents will spill or spray on caregivers, the patient, and the sterile operating/procedure area." deroyal industries, inc.Requested return of the device, and received it on 4/29/2026.Several lids were inspected with the reported defective device.The canister tip went into each of the lids with no issue.The device history record of the device was also reviewed and no issues were found with assembly or testing.A complaint to sales ratio was conducted over the past two years and was (b)(4).Root cause: the root cause was unable to be determined.The returned sample fit into the canister lids with no issue so no issue could be identified.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends 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: OUTER SHELL CANISTER, 1500CC, BRACKET
• 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 ; 8653622106
• MDR Report Key: 25003188
• Report Number: 2320762-2026-00005
• Device Sequence Number: 9773686
• Product Code: KDQ
• UDI-Device Identifier: 00749756664660
• UDI-Public: 00749756664660
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 71-1500BR
• Device Lot Number: 63207691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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