MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED

Catalog Number	072223
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that it was difficult to suction from the drain.The drain did not suction during the surgery, so the doctor opened the wound and replaced with a new drain.
Additional Manufacturer Narrative
The reported event is confirmed use-related based on the blockage despite the ifu warning the user to observe the drain and prevent blockages.Visual evaluation of the returned sample noted one opened (no original packaging present) a channel drain returned with no trocar or adapter and a bulb evacuator.The drain end submerged in water.The bulb was compressed and outlet port closed, the and suctioned no water.The drain was disconnected and the bulb was tested without the drain to ensure the evacuator functioned with no issues.The drain was dissected to identify human tissue and blood clogging the end of all of the channels.No further functional testing of the drain could be done since the drain was dissected and unable to maintain vacuum.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿ indications: wound drains are used to remove exudates from wound sites.Warnings: an effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir suction must be maintained in order for the system to function properly.Verify that the system is functioning properly.If the system is not maintained properly, surgical complications, including hematomas, may result.In the event of occlusion of the drain, all wound drainage via the drain ceases.Careful attention to the drain will minimize the possibility of this problem.If occlusion does occur, the drain can be aspirated by connecting suction to the reservoir outlet or temporarily disconnecting the drain from the reservoir and applying suction directly to the drain.If an air-tight seal between the drain and the skin where the drain emerges is not achieved, the air leak must be rectified or the system must be converted to open drainage.An airtight seal between all system components (drain, adaptor and reservoir) is necessary for proper system function.Leaving the soft silicone elastomer drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may effect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.Evacuators should be used in cardio-thoracic surgery only after the lung is fully expanded and all air leaks have sealed.Drain perforations or channels must lie within the wound or cavity to be drained, otherwise inadequate drainage may result.To avoid the possibility of drain damage or breakage: avoid suturing through drains.Drains should lie flat and in line with the skin exit areas.Particular care should be taken to avoid any obstacles to the drain exit path.Drains should be checked for free motion during closure to minimize the possibility of breakage.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Surgical removal may be necessary if drain is difficult to remove or breaks.Complications: complications which may result from the use of this suction drainage system include the risks associated with methods utilized in the surgical procedure, as well as the patients degree of intolerance to any foreign object in the body.The advantages of wound drainage, particularly closed system drainage, are lost if an air-tight seal between the drain and the skin where the drain emerges is not achieved, or if the drain is allowed to become occluded or if the reservoir is not activated properly, doesn¿t function properly or is not monitored.Evacuators should be emptied and re-activated when required per hospital protocol.Drain placement the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.Tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.Deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.Care must be exercised to avoid damage to the drain (see warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.".
Event or Problem Description
It was reported that it was difficult to suction from the drain.The drain did not suction during the surgery, so the doctor opened the wound and replaced with a new drain.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8004378
• Report Number: 1018233-2018-04971
• Device Sequence Number: 13494096
• Product Code: GBX
• UDI-Device Identifier: 00801741049842
• UDI-Public: (01)00801741049842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 072223
• Device Lot Number: NGCQ1057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1