MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER; CATHETER TRAY

Model Number	772514
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿incomplete or inadequate labeling¿.A potential root cause for this failure could be "missing, incorrect, or illegible non-critical label or package items".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:"visually inspect the product for any imperfections or surface deterioration prior to use.".
Event or Problem Description
It was reported that the iodine swabsticks and latex gloves were missing from the tray.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8808612
• Report Number: 1018233-2019-04066
• Device Sequence Number: 16853766
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/19/2019

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 Expiration Date: 04/30/2021
• Device Model Number: 772514
• Device Catalogue Number: 772514
• Device Lot Number: NGCU3708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1