MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. 2500CC RIGID CANISTER; BOTTLE, COLLECTION, VACUUM

Model Number 71-1107

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Root cause: at this time, a root cause could not be determined because a sample has not been returned for inspection.Quality control has reached out to the user facility to obtain samples.Testing was initiated using samples from inventory to try to reproduce the reported failure.However, this was only accomplished by intentionally delivering impact to the canister with an external force.Corrective action: a corrective action has not been taken at this time due to the root cause determination.If a sample or more information becomes available, the complaint investigation will be reopened.Investigation summary an internal complaint ((b)(4)) was received indicating that a rigid canister ((b)(4)) "exploded" during use.A sample was initially reported to not be available.However, pictures of the reported incident were provided.Deroyal quality control has been in contact with the user facility to obtain samples for evaluation.If samples are received and evaluation completed, the complaint investigation will be reopened.The user facility was contacted to obtain more information about how the product was used.A typical wall hookup was reportedly in use at the time of the event.Inventory evaluation was conducted september 27, 2017.An extended vacuum test was conducted by applying a vacuum source tubing to the canister lid and closing all other ports.The canister must remain on test for no less than 24 hours at a minimum of 27inhg.The item number used for this testing was v71-1107 instead of 71-1107; however, this is the same canister packaged for a specific account.No product was available packaged as 71-1107.During inventory evaluation, a canister with a hairline crack along the bottom was tested but would not develop negative pressure due to the crack.Another canister with a crack halfway across the bottom was tested, and after applying to the vacuum, the crack extended across the bottom and vacuum was lost as a result.Two canisters were placed on vacuum and received intentional impact from an external force.This resulted in one canister imploding and a chunk separating from the bottom of another canister.Four canisters were cleaned with a sanitizing wipe found in some medical settings that is known to attack polycarbonate.The canisters quickly showed crazing where the chemical is attacking the styrene; however, the canisters did not fail to hold suction for 24 hours.This chemical reaction could not be observed in the pictures provided.The current packaging configuration for the reported finished good has been in effect since january 2012.This is the first reported incident of its kind since the date the packaging configuration was implemented.Therefore, the packaging was ruled out as a potential root cause.The initial report did not indicate the type of procedure the product in which the product was used.The canister is not indicated for use in pleural drainage or liposuction procedures.Deroyal has confirmed the defective canister was not used during such procedures.During the course of this investigation, it was identified that the instructions for use indicate the product is not intended to be used for pleural drainage; however, it does not state the product is not intended for use in liposuction.Marketing communications was notified of this discrepancy and confirmed that the ifu needs to be updated.From september 2016 to present, (b)(4).Preventive action: a preventive action has not been taken at this time.The investigation is complete.If a sample or more information becomes available, this report will be updated.

Event Description

The suction canister "exploded" the bottom of the canister, creating a large hole and splashing blood from the procedure throughout the room.The canister was replaced and the spill cleaned.

• Brand Name: 2500CC RIGID CANISTER
• Type of Device: 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: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6964871
• MDR Text Key: 90754381
• Report Number: 1057404-2017-00001
• Device Sequence Number: 1
• Product Code: KDQ
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71-1107
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2017
• 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