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

Catalog Number	072510
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 device was not returned.
Event or Problem Description
It was reported that two of the ports of the 3-in-1 drain connector became unplugged during use, which introduced air into the thoracic cavity.There was no reported injury to the patient, however the complainant noted that there was a risk of respiratory compromise.The connector was being used with a single drain, so the ports that became disconnected were not in use.
Event or Problem Description
It was reported that two of the ports of the 3-in-1 drain connector became unplugged during use, which introduced air into the thoracic cavity.There was no reported injury to the patient, however the complainant noted that there was a risk of respiratory compromise.The connector was being used with a single drain, so the ports that became disconnected were not in use.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿directions for use: the adaptor is designed to support up to three (3) bard channel drains, sizes 19 fr.- 32 fr.Connect each drain individually to one of the three barbed ports with a twisting motion.Connect the first drain to the uncapped barbed port first.To connect each additional drain, remove the cap from each of the remaining barbed ports and attach the drain(s).To ensure a proper connection, insert the corresponding drain past the line shown in the diagram on page 2.If less than three (3) drains are connected to the adaptor, confirm that the remaining cap(s) are secure and cover the unused barbed ports." the device was not returned.

• Brand Name: BARD CARDIOTHORACIC ADAPTOR
• Common Device Name: DRAIN CONNECTOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8075796
• Report Number: 1018233-2018-05449
• Device Sequence Number: 2017987
• Product Code: GCE
• UDI-Device Identifier: 00801741050046
• UDI-Public: (01)00801741050046
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 10/23/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1