MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CARDIOTHORACIC ADAPTOR; BARD THREE-IN-ONE DRAIN CONNECTOR

Catalog Number	072510
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Discomfort (2330)
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 additional ports were accidentally opening, and the bulkiness of the drain caused discomfort.Health professional stated they were concerned that the bulkiness could cause skin breakdown post cardiac surgery.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿product damaged upon arrival¿ with a potential root cause of "inappropriate package design".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Pk7644301 11/2016 manufacturer: c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 www.Bardmedical.Com assembled in mexico consult instructions for use.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.".
Event or Problem Description
It was reported that additional ports were accidentally opening, and the bulkiness of the drain caused discomfort.Health professional stated they were concerned that the bulkiness could cause skin breakdown post cardiac surgery.

• Brand Name: BARD CARDIOTHORACIC ADAPTOR
• Common Device Name: BARD THREE-IN-ONE DRAIN CONNECTOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9416523
• Report Number: 1018233-2019-07741
• Device Sequence Number: 11493553
• Product Code: GCE
• UDI-Device Identifier: 00801741050046
• UDI-Public: (01)00801741050046
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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 Catalogue Number: 072510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1