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

Model Number	400618
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 catheters were coming bent and not packed properly in the box.Per customer, the boxes are in perfect shape, and the catheters inside are the problem.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.There were no photos or physical samples received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.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, 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: 21585258
• Report Number: 1423537-2025-00126
• Device Sequence Number: 9275725
• Product Code: KOD
• UDI-Device Identifier: 10884521008939
• UDI-Public: 10884521008939
• 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): 03/26/2025

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: 400618
• Device Catalogue Number: 400618
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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