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

Model Number	365718
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	06/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 inserted on (b)(6) 2018 and a scan showed that the patient retained over 500 cc.Upon insertion of the catheter, 550 cc was drained from the patient's bladder.It was later noted that there was not any output.The foley was manipulated and 350cc of urine drained into the drainage bag.

• Brand Name: BARD® 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: 7764180
• Report Number: 1018233-2018-03485
• Device Sequence Number: 16473713
• Product Code: EZC
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: Health Professional
• Device Model Number: 365718
• Device Catalogue Number: 365718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1