MAUDE Adverse Event Report: C. R. Bard, Inc. SureStep¿ Foley Tray System; CATHETER, COUDE

Model Number	A304914
Medical Device Problem Codes	No Flow (2991); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
14 f coude cath that was placed and patient partially pulled out.It did not come out all of the way and rn went to pull the fluid from the balloon but it did not withdraw.Tried many different syringes and fluid still did not withdraw.Cut the catheter tubing as a last resort and fluid still did not come out of balloon.

• Brand Name: SureStep¿ Foley Tray System
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. Bard, Inc.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 50838815
• Report Number: 50838815
• Device Sequence Number: 10278282
• Product Code: EZC
• UDI-Device Identifier: 00801741104350
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

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: A304914
• Device Catalogue Number: A304914
• Device Lot Number: NGLN0448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 09/02/2026