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

Model Number	PHESL-1000B
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility complaint was received on 1/30/2023, reporting, "suction fails, patients aspirating worry." the sample has not yet been returned to deroyal for evaluation.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation.
Event or Problem Description
"suction fails, patients aspirating worry.".

• Brand Name: SAFELINER SUCTION CANISTER
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928695
• Report Number: 2320762-2023-00002
• Device Sequence Number: 2725467
• Product Code: KDQ
• UDI-Device Identifier: 00749756664646
• UDI-Public: 00749756664646
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 02/28/2023

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
• Device Model Number: PHESL-1000B
• Device Lot Number: 58375892
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 08/07/2024
• 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