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
Event or Problem Description
"suction fails, patients aspirating worry.".
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.
Additional Manufacturer Narrative
Five samples were returned to deroyal on feburary 3, 2023.The samples were leak tested and confirmed to be suctioning improperly.To further investigate, each lot that was in stock of products phesl-1000b were pulled and tested from deroyal distribution center.Each of the lots, with 34 from each lot, were leak tested and passed.Complaints records were reviewed between 2021-2022.Within this timeframe, (b)(4) cases of part phels-1000b were sold with (b)(4) complaints filed.This is a ratio of (b)(4).Production records were reviewed within the timeframe of this complaint and it was identified that the newest variable in product was an injection-molding machine that is a higher tonnage machine that what the lide is typically ran on.It was determined that the fill time on one of the five lots returned was faster than the spec.This faster fill time was recreated and was found to yield unacceptable parts.From this investigation, deroyal isolated the malfunction to one lot and initiated a recall (# 6034-0215.23) to remove the affected lot from the field.Root cause: the root cause was determined to be due to an inadequate process control of the validation process, lack of resources, as well as deviations of procedural requirements.Due to this issue, a recall (# 6034-0215.23) was issued.A capa was assigned tp the branch plant with the non-conformance to address the issue.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
• 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: 19929628
• Report Number: 1057404-2023-00005
• Device Sequence Number: 2760100
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• 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