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

Model Number	0134L20
Medical Device Problem Code	Misassembled (1398)
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 urine flow was limited.Per email received from the ibc representative on (b)(6) 19, yes, there was a little urine flow, but allegedly the flow was not smooth and properly.Per email received from the investigator on (b)(6) 2019, it was found the that the length of both drainage eyes from the tip was above specifications for both catheters.
Event or Problem Description
It was reported that the urine flow was limited.Per email received from the ibc representative on (b)(6)2019 , yes, there was a little urine flow, but allegedly the flow was not smooth and properly.Per email received from the investigator on (b)(6)2019, it was found the that the length of both drainage eyes from the tip was above specifications for both catheters.
Additional Manufacturer Narrative
The reported event was confirmed.Two 3 way lubricath irrigation foleys were returned.It was found that all of the drainage eyes' tip length on both catheters were found to be above specifications.A potential root cause for this failure could be "drainage eyes too far from tip".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".

• Brand Name: BARDEX®LUBRICATH® FOLEY CATHETER ALCOCK MODEL
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9172283
• Report Number: 1018233-2019-06361
• Device Sequence Number: 2739611
• Product Code: KOD
• UDI-Device Identifier: 00801741018763
• UDI-Public: (01)00801741018763
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: 0134L20
• Device Catalogue Number: 0134L20
• Device Lot Number: MCCT3614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1