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

Model Number	71-6530
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Suction Problem (2170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the exact root cause could not be determined.The samples returned by the end user did not display the reported defect.The failure reported -- the fluid did not reach the filter and the outer shell had fluid after the occurrence -- would indicate the suction liner did perform as intended due to either a manufacturing defect or shipping damage.The reported failure could only be reproduced during the investigation by intentionally creating a hole in the liner wall or on the bottom of the liner.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received indicating that a 3000 cc safeliner suction canister (part number 71-6530) failed during use, allowing fluid to back fill into the tubing line.The end user reported additional similar instances that have been entered as complaints (calls (b)(4)).The defective sample was discarded.However, the end user returned representative samples may 24, 2018.The samples returned included part number 71-6530 (lot number 47307211) as well as 5 bags at 10 per bag of 3000 cc lids, 19 loose 3000 cc lids, 35 3000 cc liners, and 3 of the 1000 cc liners.The investigator was unable to confirm that lot 47307211 was the affected lot because the quantity returned exceed the selling unit of measure.The product returned was visually inspected and parts found to be damaged (rim chipped) or containing visual flaws (bubbles in the bottom) were functionally tested.All samples passed.The deroyal sales representative for the account in question was contacted regarding these occurrences.After a meeting with the account on may 15, 2018, the sales representative explained that the fluid did not come into contact with the filter, and fluid was present in the outer shell after the occurrence.This is indicative of the liner having a hole or crack.Had the filter failed to perform its function, the outer shell would not have had fluid in it, and the fluid would have been in contact with the filter.In accordance with manufacturing facility protocol (rpp.Mfg.100), the liner/lid assembly undergoes shutoff testing where fluid is pulled into the unit via vacuum.Once the unit fills to approximately 90 percent capacity, the canister valve (filter) will activate.The unit is to remain on vacuum for no less than 2 minutes without fluid passing through the filter.Currently, this is an isolated occurrence with one account.The complaint-to-sales ratio is (b)(4) for this canister size for the month of may.This is the first complaint for this part number in 2018.Preventive action: a preventive action has not been taken at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The suction canister did not work properly.Fluid back filled into the tubing line during surgery in the operating room (or).

• Brand Name: SAFELINER SUCTION CANISTER
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• MDR Report Key: 7561351
• Report Number: 1057404-2018-00002
• Device Sequence Number: 1946151
• Product Code: KDQ
• UDI-Device Identifier: 00749756665810
• UDI-Public: 0749756665810
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 71-6530
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1