MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® CLOSED SYSTEM FOLEY CATHETER TRAY; BARDIA TRAY

Model Number	802016
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 the lubricant was missing from the tray.
Additional Manufacturer Narrative
The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be " components / missing accessories".A potential root cause for this failure could be" incorrect operation".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: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.".
Event or Problem Description
It was reported that the lubricant was missing from the tray.

• Brand Name: BARDIA® CLOSED SYSTEM FOLEY CATHETER TRAY
• Common Device Name: BARDIA TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8607592
• Report Number: 1018233-2019-02484
• Device Sequence Number: 16609360
• Product Code: EZC
• UDI-Device Identifier: 00801741019678
• UDI-Public: (01)00801741019678
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 01/31/2021
• Device Model Number: 802016
• Device Catalogue Number: 802016
• Device Lot Number: NGCT4406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1