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

Model Number 71-1107

Device Problems Burst Container or Vessel (1074); Crack (1135); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

Root cause: the root cause is unable to be determined.No samples have been returned for evaluation.The reported issue could not be reproduced during internal testing.Corrective action: a corrective action has not been taken at this time due to the root cause determination.Investigation summary: an internal complaint (call (b)(4)) was received reporting occurrences of 2500cc canisters (finished good 71-1107) having hairline fractures, causing them to "explode" under vacuum.Samples were reported to be available for return.However, as of the date of this report, these have not been returned for evaluation.The complaint investigator has made repeated attempts to obtain the samples from the end user.If and when the samples are received, this investigation will be reopened.This is the second report of this nature for the affected product number.The previous report (call (b)(4)) was from a different end user.The root cause in this incident was unable to be determined due to the absence of samples for evaluation and the inability to reproduce the reported failure in internal testing.This testing included resistance to implosion testing (iso 10079-3:2014), extended vacuum testing (27 inhg minimum for 24 hours), and implosion by external pressure (25 psi minimum).The deroyal sales representative assigned to this account was contacted during the investigation.The representative indicated that multiple accounts in this region are using the canisters for liposuction.These canisters are not indicated for liposuction or pleural drainage.During the course of the investigation, it was identified the instructions for use states the product is not for use for pleural drainage, but does not include liposuction in this statement.This change to the ifu is in the change order request phase.The packaging for the finished good number has not changed since january 2012.The complaint investigator looked at finished good canisters utilizing the same outer box as the 71-1107, and none of these parts have been reported to have this issue.The investigation is complete at this time.If and when new and critical information is received, this report will be updated.

Event Description

The waste fluid suction canisters have hairline fractures in them.When put under suction pressure, the canisters explode.

• Brand Name: 2500CC 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: 6999871
• MDR Text Key: 91465493
• Report Number: 1057404-2017-00002
• 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: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• 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