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

Model Number	71-2051
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell, tn
• MDR Report Key: 9818143
• Report Number: 2320762-2020-00001
• Device Sequence Number: 11467558
• Product Code: KDQ
• UDI-Device Identifier: 00749756296946
• UDI-Public: 00749756296946
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71-2051
• Device Lot Number: 51627241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1