MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ECO RIGID CANISTER, 2500CC W/2 ELBOWS; BOTTLE, COLLECTION, VACUUM

Model Number	71-8004
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "this occurred at least 2 times with suctions anesthesia providers were using.To my knowledge the correct ports are being used.We do not use any solidifier until the procedure is completed (to ensure accurate tracking of fluid output).During these 2 instances the suction had been working but stopped mid procedure." deroyal industries, inc.Requested return of the device, but it was unavailable for return.This investigation is ongoing and not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "this occurred at least 2 times with suctions anesthesia providers were using.To my knowledge the correct ports are being used.We do not use any solidifier until the procedure is completed (to ensure accurate tracking of fluid output).During these 2 instances the suction had been working but stopped mid procedure.".
Additional Manufacturer Narrative
A user facility reported, "this occurred at least 2 times with suctions anesthesia providers were using.To my knowledge the correct ports are being used.We do not use any solidifier until the procedure is completed (to ensure accurate tracking of fluid output).During these 2 instances the suction had been working but stopped mid procedure." deroyal industries, inc.Requested return of the device, but it was unavailable for return.Deroyal reviewed specifications for the canister, however, because no lot number was provided, the specific work order could not be reviewed.An inventory check was not able to be performed as none of the 71-8004 canisters were on hand.Failure modes and effects analysis (fmea) and corrective and preventive actions (capas) were reviewed for the canisters, but no updates nor capas were required.A complaint to sales analysis was completed over the past two years and found to be (b)(4).Root cause: because no samples nor lot numbers were returned and no issues were found within the investigation, no root cause was able to be determined.Potential root cause: while the true root cause cannot be determined due to no samples being returned for investigation, it is most likely the reported failures of suction during procedure after it had been working prior are due to the filter becoming wet prematurely and shutting off.If fluids are inadvertently introduced to the vacuum port as opposed to the patient port by improper hook up the filter in the lid becomes wet.If fluids/vacuum are then reapplied to the correct ports on the lid the filter will still shut off and suction will be lost.If the canister is tilted with fluids inside there is a potential the fluids will come into contact with the filter, the filter will then shut off after this occurs.Corrective and preventive actions: because no root cause could 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: ECO RIGID CANISTER, 2500CC W/2 ELBOWS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22285326
• Report Number: 1057404-2025-00021
• Device Sequence Number: 8893346
• Product Code: KDQ
• UDI-Device Identifier: 00749756354974
• UDI-Public: 00749756354974
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 71-8004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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