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

Catalog Number	072223
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2017
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.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that body fluid was not aspirated.The drain tube was connected to the suction device, and negative pressure was applied.There was no patient injury reported and a limited procedure delay occurred.The suction evacuator was replaced and the treatment was completed.
Additional Manufacturer Narrative
Received 1 channel drain.The reported issue was unconfirmed, as the problem could not be reproduced.Per visual inspection the suture was noted on the channel drain to be 0.7100¿ from tube.During functional evaluation, the drain was connected to the inlet port of the evacuator and the end of the drain was submerged into water, the evacuator was compressed and rolled over which was kept compressed by the hand, and then, the outlet port was closed.The evacuator suctioned 100cc of water without any difficulties.In addition, it was noted that the evacuator recovered its original shape once it suctioned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "indications: bard® channel drains, round and flat silicone, are indicated for use with selected bard® evacuators for closed wound drainage following head and neck, orthopedic, abdominal, ent, ob/gyn, plastic, neurosurgery, thoracic and cardiovascular (channel drains only) procedures.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." (b)(4).
Event or Problem Description
It was reported that body fluid was not aspirated.The drain tube was connected to the suction device, and negative pressure was applied.There was no patient injury reported and a limited procedure delay occurred.The suction evacuator was replaced and the treatment was completed.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED
• Common Device Name: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6723496
• Report Number: 1018233-2017-03791
• Device Sequence Number: 1161314
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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 Catalogue Number: 072223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1