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

Model Number V71-6530

Device Problems Filtration Problem (2941); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

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 (b)(4)) 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 lot number affected, 12 samples were subjected to this testing with no failures reported.In may 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.Past reports for this item number were reviewed.One previous report has been received for the same issue involving the same part number.This is isolated to one account.The investigation is complete at this time.If new or critical information is received, this report will be updated.

Event Description

During use of a suction canister, fluid backflowed into the hospital vacuum system.

• Brand Name: SAFELINER SUCTION CANISTER
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell, tn
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, tn ; 3626112
• MDR Report Key: 10459412
• MDR Text Key: 206159354
• Report Number: 1057404-2020-00006
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 50749756728961
• UDI-Public: 50749756728961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2020

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 Operator: Health Professional
• Device Model Number: V71-6530
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1