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

Model Number 71-6510

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2018

Event Type  malfunction  

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 1000cc safeliner suction canister (part number 71-6510) 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 ((b)(4)).The defective sample was discarded.However, the end user returned representative samples (b)(6) 2018.The samples returned included part number 71-6530 (lot number 47307211) as well as 5 bags at 10 per bag of 3000cc lids, 19 loose 3000cc lids, 35 3000cc liners, and 3 of the 1000cc liners.The part number returned is not the part associated with this report.The deroyal sales representative for the account in question was contacted regarding these occurrences.After a meeting with the account on (b)(6) 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.Year- to-date percentage is (b)(4).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 Description

The suction canister did not work properly.Fluid back filled into the tubing line during surgery in the or.

• Brand Name: SAFELINER SUCTION 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: 7561359
• MDR Text Key: 109891124
• Report Number: 1057404-2018-00001
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00749756665728
• UDI-Public: 0749756665728
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71-6510
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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