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

Model Number	772415
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 the betadine swabs were missing from the kit.No medical intervention was required.
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: **red rubber catheter, 15 fr.Uro-prep¿ tray with: underpad, drape povidone-iodine swabsticks (3) specimen container and label synthetic vinyl gloves (2) lubricant graduated collection container.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: contents of inner wrap are sterile unless package is opened or damaged.Directions for use on reverse side.Single use only.Do not resterilize.For urological use only." the device was not returned.
Event or Problem Description
It was reported that the betadine swabs were missing from the kit.No medical intervention was required.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: INTERMITTENT CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8308463
• Report Number: 1018233-2019-00630
• Device Sequence Number: 2120590
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413(10)
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2019

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: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGCS1854
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1