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

Model Number	8888492025
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the catheter was broken in half and some pieces detached from the tip.Additional information was received from the customer and stated that the issue was discovered after used on a patient.It was intact in the package.Per customer, probably pieces were left in patient, but no way to know if there was still pieces left.There was no harm known at this time.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2324713864 was reviewed and no anomalies related to the reported issue were observed.Two pictures were provided for analysis, and upon reviewing the pictures, the reported issue was observed.The physical device was not returned for evaluation.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• 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; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22187781
• Report Number: 1423537-2025-00239
• Device Sequence Number: 8588527
• Product Code: KOD
• UDI-Device Identifier: 10192253030327
• UDI-Public: (01)10192253030327(10)2324713864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K810216
• 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): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888492025
• Device Catalogue Number: 8888492025
• Device Lot Number: 2324713864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown