MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ECO RIGID CANISTER, 1500CC W/2 ELBOWS; BOTTLE, COLLECTION, VACUUM

Model Number	71-8003
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User faclity reported "canister would not suction; changed the canister 2x until one worked; discarded".
Additional Manufacturer Narrative
A user facility reported, "the canister would not suction.They changed the canister 2x until one worked." deroyal industries requested return of the sample, but it was not available for return.An incorrect lot number was also provided, so no lot was able to be reviewed.Deroyal reviewed specifications, failure modes and effects analysis (fmea), and any corrective and preventive actions (capas) relevant and no issue were found.An inventory check was performed on 32 suction canisters and all were found to be within specification.40 parts were pulled from inventory to be tested.20 lids were tested with vacuum being applied to the vacuum port and water was pulled into the canister.Each lid functioned as intended.20 lids were then tested by applying vacuum to the patient port and attempted to pull water into the vacuum port.When the lid is hooked up in this manner, the filter immediately becomes wet and suction declines rapidly.This shows shut-off testing passed and no fluid was permitted into the canister.(b)(4).Root cause: because no sample or photos were returned, the root cause could not be determined.Potential root cause: using the customer description of the problem and testing conducted, a possible root cause of this failure is a user hook up error.If fluids are pulled into the vacuum port, the filter will shut off immediately and prevent fluids from reaching the canister and prevent suction.Corrective and preventive actions: because no root cause could be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for any 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, 1500CC 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: anita spaulding ; 200 debusk lane; powell, TN 37849 ; 8653622058
• MDR Report Key: 20084434
• Report Number: 1057404-2024-00003
• Device Sequence Number: 7811065
• Product Code: KDQ
• UDI-Device Identifier: 00749756375795
• UDI-Public: 00749756375795
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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: 71-8003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 08/28/2024
• 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