MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. 1500CC CANISTER KIT; BOTTLE, COLLECTION, VACUUM

Model Number 71-2051

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (b)(4) was received indicating the solidifier packet included within a suction canister kit (part number 71-2051, lot 51627241) broke inside the device packaging.When a nurse opened the packaging, she got solidifier in her eye.A sample was not available for return.A photograph of the reported failure was provided for review.The investigation is ongoing at this time.When new and critical information is available, this report will be updated.

Event Description

A packet of solidifier packaged in a suction canister kit broke inside the device packaging.When a nurse opened the canister packaging, some of the solidifier got in her eye.

Manufacturer Narrative

Root cause: based on investigation findings, no definitive root cause could be identified.However, the following possible root causes were identified: 1.The solidifier pack may have become punctured during handling prior to reaching the end user.The solidifier pack is designed to be soft and water-soluble, so only minor force is required to open or puncture the packaging.2.Excessive room within the product packaging allowed for the solidifier to easily shift against other components, causing the pack to rupture.Corrective action: adjustments to the packaging have been made to achieve a more secure fit around the solidifier and other components within the kit.Training was performed for employees responsible for the reported lot.It was stressed to employees running the machine to use the correct amount of shrink film.Investigation summary an internal complaint ((b)(4)) was received indicating the solidifier packet included within a suction canister kit (part number 71-2051, lot 51627241) broke inside the device packaging.When a nurse opened the packaging, she got solidifier in her eye.A sample was not available for return.A photograph of the reported failure was provided for review and confirmed the reported event.It was noted that the packaging around the components was loose, allowing for extra room to shift within the pack.A review of quality records shows no discrepancies during manufacturing that would have contributed to the reported event.Finished good inventory on hand was checked and no issues were found.Deroyal has sold (b)(4) cases of finished good 71-2051 from (b)(6) 2018 to present.During this period, two unrelated complaints were received for this product, yielding a complaint-to-sales ratio of (b)(4).Deroyal will continue to monitor post-market feedback and will recognize in the future if a trend develops.The investigation is complete at this time.If new and critical information is available, this report will be updated.

Event Description

A packet of solidifier packaged in a suction canister kit broke inside the device packaging.When a nurse opened the canister packaging, some of the solidifier got in her eye.

• Brand Name: 1500CC CANISTER KIT
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell, tn
• MDR Report Key: 9818143
• MDR Text Key: 203134409
• Report Number: 2320762-2020-00001
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00749756296946
• UDI-Public: 00749756296946
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71-2051
• Device Lot Number: 51627241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1