MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN NOVAPLUS

Catalog Number	V072231
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
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 when the surgeon attempted to remove the channel drain after an "above knee amputation," the drain broke off in the patient's leg.The complainant reported that the patient had to return to the or to have the broken piece of the drain retrieved.The broken fragment reportedly came out in one piece.
Event or Problem Description
It was reported that when the surgeon attempted to remove the channel drain after an "above knee amputation," the drain broke off in the patient's leg.The complainant reported that the patient had to return to the or to have the broken piece of the drain retrieved.The broken fragment reportedly came out in one piece.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the retuned sample noted one broken portion (5.2260" long) of a novaplus four channel drain in a sample cup.No original packaging was present.The drain was broken on one end, with a jagged and uneven surface.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: ¿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." patient code: (b)(4).

• Brand Name: CHANNEL DRAIN NOVAPLUS
• Common Device Name: CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8204178
• Report Number: 1018233-2018-06256
• Device Sequence Number: 264011
• Product Code: GBX
• UDI-Device Identifier: 00801741119200
• UDI-Public: (01)00801741119200
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: V072231
• Device Lot Number: NGCV0179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention