MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE; COUDE CATHETER

Model Number	0102L18
Health Effect - Clinical Code	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 information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that the catheter was leaking from an unknown source.
Additional Manufacturer Narrative
Received 1 coude tip catheter in open packaging.The reported event was unconfirmed.The exterior of the sample was visually examined and did not find anything to contribute to the reported event.Per the functional evaluation, the balloon was inflated with air while submerged in water and did not find any leakage.The drainage lumen was examined and did not find a blockage.The reported event was unable to be duplicated.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that the catheter was leaking from an unknown source.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6742970
• Report Number: 1018233-2017-03970
• Device Sequence Number: 19143215
• Product Code: EZC
• UDI-Device Identifier: 00801741018138
• UDI-Public: (01)00801741018138
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2017

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: 03/31/2021
• Device Model Number: 0102L18
• Device Catalogue Number: 0102L18
• Device Lot Number: RW6101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 11/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1