MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SAFELINER SUCTION CANISTER, 1500CC; BOTTLE, COLLECTION, VACUUM

Model Number	PHESL-1500B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that a safe liner canister burst and the contents went everywhere in the or.
Additional Manufacturer Narrative
A user facility reported that the safeliner burst and the contents went everywhere in the or.Deroyal requested return of the device and it was received on december 20, 2024 to be evaluated.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.
Additional Manufacturer Narrative
A user facility reported that the safeliner burst and the contents went everywhere in the or.Deroyal requested return of the device and it was received on december 20, 2024, to be evaluated.Upon visual inspection of the returned device, no visual defects could be found.No observable defects of the manufacturing of the parts could be found, the only potential issue noted was that there was an area of the glue bead that was thin.There is a potential that this could cause a leak between the liner and the lid, however this would not have the potential to create the situation described of the canister bursting.Testing was also conducted on a safeliner and outer shell assembled to recreate the setup.While the assembly was still under vacuum, the patient, tandem, and pour spout caps were removed one at a time before also removing the vacuum hos to observe how much fluid would be pushed out fo the assembly due to a sudden loss of vacuum.A small amount of fluid was observed leaving the assembly; however, it was not of the same magnitude of the complaint showing a burst canister.This was test was the only way to found to influence a fluid filled safeliner canister to push its own contents outward.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: no root cause could be confirmed from the investigation.Corrective and preventive actions: no corrective actions were taken due to the root cause being undetermined.However, a glue acceptance criteria re-training was conducted out of an abundance of caution.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 if additional information becomes available.

• Brand Name: SAFELINER SUCTION CANISTER, 1500CC
• 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: 21003798
• Report Number: 1057404-2024-00011
• Device Sequence Number: 9850565
• Product Code: KDQ
• UDI-Device Identifier: 00749756377058
• UDI-Public: 00749756377058
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: PHESL-1500B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• 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): 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