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

Model Number	0168L16
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Nursing tested balloon on catheter before inserting into patient; balloon would not deflate when attempted to remove sterile water.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 20646712
• Report Number: 20646712
• Device Sequence Number: 15513302
• Product Code: EZC
• UDI-Device Identifier: 00801741017827
• UDI-Public: (01)00801741017827(17)28053(10)
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/03/2024
• Report Date (Section F): 10/03/2024

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: 0168L16
• Device Catalogue Number: 0168L16
• Device Lot Number: NGJS2875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/03/2024