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

Model Number	8888492041
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) for lot 2327517364 was reviewed and no anomalies related to the reported issue were observed.A few pictures were provided for analysis, and upon reviewing the pictures, the reported issue was observed.A physical device was returned for evaluation and the reported issue was not observed on the returned sample.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.
Event or Problem Description
The customer reported that the product in the box was defective, tip of the catheters was bent because of the way it was packaged.The customer tried to use the product, but it caused bleeding.The customer orders this item regularly and never experienced issues.Additional information was received from the customer and stated that there was no medical intervention or treatment required.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.See section h6 codes (health effect - impact code): updated to 2199: no health consequences or impact.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the product in the box was defective, tip of the catheters was bent because of the way it was packaged.The customer tried to use the product, but it caused bleeding.The customer orders this item regularly and never experienced issues.

• 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, INC.; 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: 21665209
• Report Number: 1423537-2025-00134
• Device Sequence Number: 7756233
• Product Code: KOD
• UDI-Device Identifier: 10192253030341
• UDI-Public: (01)10192253030341(10)2327517364
• 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,Followup
• Report Date (Section B): 06/20/2025

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: 8888492041
• Device Catalogue Number: 8888492041
• Device Lot Number: 2327517364
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 03/26/2025; 06/20/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown