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

Model Number	PHESL-1500B
Medical Device Problem Codes	Fluid/Blood Leak (1250); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "we are having difficulty with canister liner contents getting into the plastic section of the suction head.Nursing leadership experimented with water and determined that the value to keep fluid from leaking out of the liner into the canister and suction head is not working thus leading to urine and other fluids contaminating the suction head and needing to be sent to sterile processing for cleaning." deroyal industries, inc.Requested return of the device, however it was unavailable for return.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
A user facility reported, "we are having difficulty with canister liner contents getting into the plastic section of the suction head.Nursing leadership experimented with water and determined that the value to keep fluid from leaking out of the liner into the canister and suction head is not working thus leading to urine and other fluids contaminating the suction head and needing to be sent to sterile processing for cleaning".
Additional Manufacturer Narrative
A user facility reported, "we are having difficulty with canister liner contents getting into the plastic section of the suction head.Nursing leadership experimented with water and determined that the value to keep fluid from leaking out of the liner into the canister and suction head is not working thus leading to urine and other fluids contaminating the suction head and needing to be sent to sterile processing for cleaning." deroyal industries, inc.Requested return of the device, however it was unavailable for return.Deroyal reviewed the work order for the lot reported.An inventory check was performed on 34 canisters from the reported lot retained at the distribution facility.Canisters were found to have glue bead issues in both visual inspection and in testing.A review of the risk analysis was conducted and no updates were required.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: the root was determined to be an inadequate glue bead or overlapping of glue bead.This could cause high or low spots that could allow for a leak path.Corrective and preventive actions: a retraining of employees on visual acceptance of the glue bead was conducted.The lid evaluation form was also updated to include that the visual check be conducted and recorded for glue bead adequacy.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: 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 facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21880692
• Report Number: 1057404-2025-00014
• Device Sequence Number: 8641380
• Product Code: KDQ
• UDI-Device Identifier: 50749756377053
• UDI-Public: 50749756377053
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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
• Device Lot Number: 61932792
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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