MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; CATHETER, UROLOGICAL

Model Number	20518C
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the balloon deflates on its own and the device has been replaced.Additional information was received from the customer and stated that the catheter was installed on (b)(6) 2025, and in the afternoon the patient had to return to the clsc because the balloon deflated, and the catheter fell off.A new 18 fr catheter was re-installed.On (b)(6) 2025, re-installed 18fr catheter also had a balloon deflation issue and it was replaced by another 18 fr catheter and the issue happened again with the third 18 fr catheter as well.The patient had no medical intervention or treatment, but the patient experienced increased infection risk and significant discomfort.
Additional Manufacturer Narrative
The device history record (dhr) for lot l25e4991s was reviewed and no anomalies related to the reported issue were observed.An unused, sealed sample was received for evaluation, and upon technical evaluation, the reported condition was not observed.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• Brand Name: DOVER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23843093
• Report Number: 1423537-2025-00508
• Device Sequence Number: 10030025
• Product Code: KOD
• UDI-Device Identifier: 10192253024272
• UDI-Public: (01)10192253024272(17)300510(10)L25E4991S
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K833790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 20518C
• Device Catalogue Number: 20518C
• Device Lot Number: L25E4991S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown