MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887605148
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) for lot: 24b086fhx was reviewed and no anomalies related to the reported issue were observed.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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that when changing an sv morning, they had a problem with the balloon of the probe.Balloon tested beforehand but "exploded" five minutes after fitting while still in place.The balloon was inflated to 10cc.Note: several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

• Brand Name: DOVER
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24346835
• Report Number: 1423537-2026-00039
• Device Sequence Number: 15833604
• Product Code: FCM
• UDI-Device Identifier: 00884521147525
• UDI-Public: (01)00884521147525(17)290216(10)24B086FHX
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K903340
• 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): 02/24/2026

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: 8887605148
• Device Catalogue Number: 8887605148
• Device Lot Number: 24B086FHX
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/24/2026
• 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