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

Model Number	PHESL-1000B
Medical Device Problem Codes	Decrease in Suction (1146); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse couldn't get good strong suction with liner only very low pressure.
Additional Manufacturer Narrative
A user facility complaint was received on 2/2/2023, reporting, "nurse couldn't get good strong suction with liner only very low pressure".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.
Additional Manufacturer Narrative
Six samples were returned to deroyal on 02/07/2023.All samples were tested with intermittent vacuum.2 of the 6 samples failed to suction properly under leak testing.Samples from all other lots of product phels-1000b that were in deroyal's distribution center were tested.Each of the lots, with 34 from each lot, were leak tested and passed.Complaint records were also pulled.Between 2021-2022, 25029 cases of phels-1000b were sold with 8 complaints coming from that same time period leading to ratio of (b)(4).Root cause: the root cause was determined to be due to a sink mark inside the pour spout cap that affected the cap from sealing properly to prevent vacuum loss.Due to this manufacturing root cause that was discovered, a corrective and preventive action (capa) report was initiated and issued to address the cause of the malfunction.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if more 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: 19928709
• Report Number: 1057404-2023-00002
• Device Sequence Number: 19544618
• Product Code: KDQ
• UDI-Device Identifier: 00749756377041
• UDI-Public: 00749756377041
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/03/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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