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

Model Number	A902916
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to deflate 16fr foley catheter for removal but unable to.Added 2cc sterile saline and attempted to deflate again.Only able to remove 4cc.Added 2cc more, then able to deflate fully.

• Brand Name: SureStep¿ Foley Tray System Bardex® Lubricath® Foley Catheter
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. Bard, Inc.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 50838816
• Report Number: 50838816
• Device Sequence Number: 13331626
• Product Code: EZC
• UDI-Device Identifier: 00801741074073
• 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
• Device Model Number: A902916
• Device Catalogue Number: A902916
• 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: Female
• Patient Weight: 176 LB
• Date Report Sent to FDA: 09/02/2026