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

Model Number	V71-6530
Medical Device Problem Codes	Filtration Problem (2941); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the defective sample was not returned for evaluation.Therefore, the root cause could not be determined.Two potential root causes have been identified: a hookup error or a defective canister filter.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary: an internal complaint (call 50654) was received indicating fluid bypassed the filter into the hospital's vacuum system.An unused sample was provided for investigation.This sample passed shutoff testing at a low vacuum level.In accordance with manufacturing specifications, an intermittent shutoff test is conducted once per day with no fluid bypassing the filter.For the reported lot number, 12 samples were subjected to this testing with no failures reported.In (b)(6) 2020, deroyal identified a supplier issue with the filters, specifically holes in the side of the filter.The supplier was notified of this issue.Since this was identified, 100% visual inspection has been performed on the raw material.The lot numbers for the filters used in the reported finished good lot received 100% visual inspection prior to use.In 2020, (b)(4) cases of this item number have been sold.This is the second complaint received, yielding a sales-to-complaint ratio of (b)(4).The investigation is complete at this time.If new or critical information is received, this report will be updated.
Event or Problem Description
During use of a suction canister, fluid backflowed into the hospital vacuum system.

• Brand Name: SAFELINER SUCTION CANISTER
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• MDR Report Key: 10431550
• Report Number: 1057404-2020-00005
• Device Sequence Number: 14051476
• Product Code: KDQ
• UDI-Device Identifier: 50749756728961
• UDI-Public: 50749756728961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V71-6530
• Device Lot Number: 52365247
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1