MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SAFELINER SUCTION CANISTER,, 1000CC; BOTTLE, COLLECTION, VACUUM

Model Number	71-6510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the deroyal cannister lid was found to be deformed causing a leak in the suction set up." deroyal requested return of the device, however it was not available for return.The 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.
Event or Problem Description
A user facility reported, "the deroyal cannister lid was found to be deformed causing a leak in the suction set up.".
Additional Manufacturer Narrative
A user facility reported, "the deroyal cannister lid was found to be deformed causing a leak in the suction set up." deroyal requested return of the device, however it was not available for return.Because no sample, pictures, or lot number were provided, the specific investigation on the product could not be completed.In checking what lots were sent to the customer, a lot number was determined.An inventory inspection was performed on 32 lids and all were found to be acceptable.The failure modes and effects analysis (fmea) and corrective and preventive actions (capa) were reviewed and no issues were found.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: because the sample nor pictures were returned and no issues were found in the manufacturing records, no root cause could be determined.Corrective and preventive actions: no corrective or preventive actions were taken as no root cause could be determined.Deroyal will continue to monitor for trends around this item and issue.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report when if information becomes available.

• Brand Name: SAFELINER SUCTION CANISTER,, 1000CC
• 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 newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21003752
• Report Number: 1057404-2024-00012
• Device Sequence Number: 18682616
• Product Code: KDQ
• UDI-Device Identifier: 00749756665728
• UDI-Public: 00749756665728
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/06/2025

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: 71-6510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 01/06/2025
• 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