MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER; TOUCHLESS MALE CATHETER

Model Number	4A3053
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.
Event or Problem Description
It was reported that the lubricant jelly was missing from the touchless kit.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one bard touchless male urethral catheter kit in open original packaging.A small sliver of a foil packet was identified in the kit, however no lubricating jelly packet was identified in the kit.The lubricating jelly packet is part of the product structure per end item/product structure.The exact cause is unknown.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: "empty tube of lubricant into top chamber of bag so that lubricant is deposited at bottom of chamber.(caution: care should be taken not to contaminate edges or inside of bag with fingers or tube.".
Event or Problem Description
It was reported that the lubricant jelly was missing from the touchless kit.

• Brand Name: BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Common Device Name: TOUCHLESS MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8350604
• Report Number: 1018233-2019-00868
• Device Sequence Number: 2198562
• Product Code: FCM
• UDI-Device Identifier: 00801741030680
• UDI-Public: (01)00801741030680
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 4A3053
• Device Catalogue Number: 4A3053
• Device Lot Number: NGCR4557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1