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

Model Number	400614
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pain (1994)
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 tip of the catheters were bent inside the box and they couldn't insert without causing pain.
Additional Manufacturer Narrative
Section d4 (lot number): originally reported as 2326111564 and should be 2412816764, (unique identifier (udi) #): originally reported as (b)(4).
Additional Manufacturer Narrative
The device history record (dhr) for lot 2412816764 was reviewed and no anomalies related to the reported issue were observed.A few pictures and devices were received for evaluation and the reported condition was observed; however, a definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.Manufacturing personnel were notified of this complaint for awareness and all information received will be used for tracking and trending purposes.

• 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: 20736055
• Report Number: 1423537-2024-00316
• Device Sequence Number: 8377084
• Product Code: KOD
• UDI-Device Identifier: 10192253029109
• UDI-Public: (01)10192253029109(10)2412816764
• 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): 01/13/2025

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: 400614
• Device Catalogue Number: 400614
• Device Lot Number: 2412816764
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/06/2024; 01/13/2025
• 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
• Patient Sex: Unknown