MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ECO RIGID CANISTER, 1500CC W/2 ELBOWS; BOTTLE, COLLECTION, VACUUM

Model Number	71-8003
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "we had an issue tonight again where the suction was previously working earlier in the night and suddenly stopped around 0200 this morning".Deroyal industries requested return of the sample, and sample was received and evaluated.The returned sample was received at deroyal on 5/31/2024.The canister and lid were visually inspected and no issues could be found.Intermittent and vacuum decay testing were conducted on the returned sample and both tests were a passed.Deroyal reviewed specifications, failure modes and effects analysis (fmea), and any corrective and preventive actions (capas) relevant and no issue were found.An inventory check was performed on 32 suction canisters and all were found to be within specification.(b)(4).Root cause: due to the condition of the filter in the returned canister lid the true root cause has been determined to be improper hookup.If fluids are pulled into the vacuum port where suction is to be applied the filter becomes wet immediately and will shutoff.The filter will then prevent/limit suction from occurring after this shutoff.Corrective and preventive actions: because no root cause could be determined, improper hookup no corrective or preventive actions were taken.Deroyal will continue to monitor for any 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.
Event or Problem Description
User faclity reported "we had an issue tonight again where the suction was previously working earlier in the night and suddenly stopped around 0200 this morning.".

• Brand Name: ECO RIGID CANISTER, 1500CC W/2 ELBOWS
• 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: anita spaulding ; 200 debusk lane; powell, TN 37849 ; 8653622058
• MDR Report Key: 20084439
• Report Number: 1057404-2024-00004
• Device Sequence Number: 15406588
• Product Code: KDQ
• UDI-Device Identifier: 00749756375795
• UDI-Public: 00749756375795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: 71-8003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 08/28/2024
• 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