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

Model Number	3607-
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/14/2025
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 cervical foley burst when inflating inside the patient.Additional information was received from the customer and stated that it was unsure if the balloon was ruptured with a pinhole or leak.The patient described the feeling as the balloon having¿ ¿burst¿.According to the customer, the balloon had a clean tear and in one piece, though it was fully deflated.There was no treatment needed and there was no patient injury.They had to re-insert the catheter which caused unnecessary discomfort to the patient involved.
Additional Manufacturer Narrative
The device history record (dhr) for lot 3097k23qx were 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
The device history record (dhr) for lot number 3097k23qx was reviewed and no anomalies related to the reported issue were observed.The physical device was received for evaluation and found to be incomplete, as the tip section was missing.The portion from above the balloon to the tip had separated from the shaft.One intact section containing the shaft, drainage funnel, inflation funnel, and balloon were received; however, the missing section from above the balloon to the tip was not returned for analysis.During the technical evaluation, the balloon was able to inflate with 30 ml as per requirement.Since the tip section was missing, the investigation team clamped the area above the balloon for testing.The balloon inflated and deflated normally, and no signs of burst or rupture were observed.The reported condition could not be replicated with the returned sample.As a result, a definitive root cause could not be determined.Based on the findings, no corrective actions are warranted at this time.We will continue to monitor related reports to determine whether additional actions become necessary.

• 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; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23453712
• Report Number: 1423537-2025-00445
• Device Sequence Number: 9008662
• Product Code: KOD
• UDI-Device Identifier: 10192253026436
• UDI-Public: (01)10192253026436(17)280406(10)3097K23QX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K860484
• 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): 02/16/2026

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: 3607-
• Device Catalogue Number: 3607-
• Device Lot Number: 3097K23QX
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/16/2026
• 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