MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL; CATHETER, COUDE

Model Number	0196L16
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted suprapubic tube exchange.Exchange was unsuccessful.The suprapubic tube balloon would not deflate.Attempted flexible cystoscopy with multiple graspers and kumar catheter unable to puncture the balloon.Unable to place spinal needle to puncture balloon.Patient could not tolerate anymore manipulation and was sent to the o.R.For endoscopic balloon deflation.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 14282264
• Report Number: 14282264
• Device Sequence Number: 6714720
• Product Code: EZC
• UDI-Device Identifier: 00801741017926
• UDI-Public: 00801741017926
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2022
• Report Date (Section F): 04/27/2022

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: 0196L16
• Device Catalogue Number: 0196L16
• Device Lot Number: NGET2679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 99 KG
• Date Report Sent to FDA: 04/27/2022