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

Model Number	PHESL-1000B
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "canister are used by anesthesia for suction for patient care.Canisters are collapsing in the patient room.Delays caused by need to change the canister during procedures." deroyal industries requested return of the device but it has not yet been returned.This investigation is not complete at this time.No further information is available at this this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "canister are used by anesthesia for suction for [patioent care.Canisters are collapsing in the patient room.Delays caused by need to change the canister during procedures.".
Additional Manufacturer Narrative
Deroyal industries requested return of the device and received it on november 11, 2024.Two samples were returned for evaluation and were stress tested.Both samples were observed to have no signs of collapse and performed as required.To further try to determine the cause of collapse, the port inside the outer shell was plugged only allowing vacuum to come from the lid.When this happens, the liner collapses inside the outer shell and does not allow for suction.When used properly with both ports, the pressure from outside and inside the liner reach an equilibrium and prevent the liner from collapsing.An inventory check was also performed on (b)(4) items in stock and all were acceptable.Risk analysis and corrective and preventive actions were also reviewed with no issues found.(b)(4).Root cause: because no issues were found in production nor with the returned samples, the root cause was unable to be determined.Potential root cause: during testing it was found that when the inner liner port is closed off and unused, the liner will collapse inside the shell.However, this could not be confirmed to be the cause of the failure in the hospital.Corrective and preventive action: no corrective or preventive actions taken as the root was unable to be confirmed.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: 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: 20559207
• Report Number: 1057404-2024-00007
• Device Sequence Number: 12983170
• Product Code: KDQ
• UDI-Device Identifier: 00749756377041
• UDI-Public: 00749756377041
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: PHESL-1000B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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