MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DOVER; CATHETER, UROLOGICAL

Model Number	8888492041
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per customer, patient stated that catheters were bent and unusable.There was no harm reported.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed since no lot number was provided.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to determine the root cause.We will continue to monitor reports and take actions as applicable.

• Brand Name: DOVER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 23610040
• Report Number: 1423537-2025-00471
• Device Sequence Number: 9444504
• Product Code: KOD
• UDI-Device Identifier: 10192253030341
• UDI-Public: (01)10192253030341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K810216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown