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

Model Number	772514
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.
Event or Problem Description
It was reported that the tray did not include the povidone iodine pouch; however, the orange label on the outside of the tray noted that the povidone iodine pouch was included in the tray.No medical intervention was reported.
Event or Problem Description
It was reported that the tray did not include the povidone iodine pouch; however, the orange label on the outside of the tray noted that the povidone iodine pouch was included in the tray.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: "contents: plastic catheter, 16 fr., preconnected to closed system collection bag (1000ml approx.Vol.) uro-prep¿ tray with: underpad, drape povidone-iodine swabsticks (3) specimen container and label graduated collection container latex-free gloves (2) lubricant packet sterile: contents of inner wrap are sterile unless package is opened or damaged.C.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com manufactured in mexico".

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: URETHRAL CATHETERIZATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8137306
• Report Number: 1018233-2018-05883
• Device Sequence Number: 13924986
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/20/2019

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: NGCW0876
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1