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

Model Number	0165V24S
Health Effect - Clinical Code	No Information (3190)
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 stopped draining urine which reportedly led to a leak.The patient reportedly replaced the catheter and voided without further incident.
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 catheter stopped draining urine which reportedly led to a leak.The patient reportedly replaced the catheter and voided without further incident.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection of the exterior of sample found evidence of encrustation on the tip end of the sample.Inflated balloon with 10cc water and administered flow rate testing.There was no flow.The drainage lumen was filled with encrustation.This was a patient related condition, due to biological material being deposited on/in the product.This was not a manufacturing related event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states 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 stopped draining urine, which reportedly led to a leak.The patient replaced the catheter and voided without further incident.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7002789
• Report Number: 1018233-2017-05709
• Device Sequence Number: 2004912
• Product Code: EZC
• UDI-Device Identifier: 00801741039430
• UDI-Public: (01)00801741039430
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2018

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: 04/20/2021
• Device Model Number: 0165V24S
• Device Catalogue Number: 0165L24
• Device Lot Number: FG6172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 01/17/2018
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 11/14/2017; 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1