MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ECO RIGID CANISTER, 1200CC W/2 ELBOWS; BOTTLE, COLLECTION, VACUUM

Model Number	71-8002
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, " these suction canisters are not suctioning properly, on 3 west we had an urgent situation in which a trach patient needed suctioned and we went through 3 different suction canisters and none of them were suctioning properly, they all had very little suction coming out of them even though the suction regulator was turned all the way up.The lid was on correctly, the suction was set up properly, there was just not enough suction.We had to open the crash cart just to get one of the old canisters (with a white lid) that we used before this one, and thankfully we also had another that did work.This product is frequently needed in emergency situations and it is with a extremely important that this product works without fail every single time.In an emergency situation there is not time to fiddle around suction canister to figure out what is going wrong, suction is always an urgent need.".
Additional Manufacturer Narrative
A user facility reported, "these suction canisters are not suctioning properly, on 3 west we had an urgent situation in which a trach patient needed suctioned and we went through 3 different suction canisters and none of them were suctioning properly, they all had very little suction coming out of them even though the suction regulator was turned all the way up.The lid was on correctly, the suction was set up properly, there was just not enough suction.We had to open the crash cart just to get one of the old canisters (with a white lid) that we used before this one, and thankfully we also had another that did work.This product is frequently needed in emergency situations and it is with a extremely important that this product works without fail every single time.In an emergency situation there is not time to fiddle around suction canister to figure out what is going wrong, suction is always an urgent need." a sample was requested but could not be returned.Production records, including work orders and failure modes and effects analysis (fmea)'s, were reviewed and no issues were found.An inventory check of 34 canisters was made and no issues were found.Root cause: because the sample was not returned and no issues were found with production, no root cause could be established.In an effort to reproduce the issue reported and try to determine a potential root cause, an eco 1200cc lid and canister base were obtained, assembled, and tested.From this testing it was determined that the potential root cause could be clinician error and/or assembly error.(b)(4).Deroyal will continue to monitor for trends surrounding 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: ECO RIGID CANISTER, 1200CC 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: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950644
• Report Number: 1057404-2023-00006
• Device Sequence Number: 8856636
• Product Code: KDQ
• UDI-Device Identifier: 00749756375788
• UDI-Public: 00749756375788
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 71-8002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown