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

Model Number	1621
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 after 1 day since dwelling the balloon, it was coming off.Upon checking, the balloon was broken.No patient injury.
Additional Manufacturer Narrative
Section d4: udi-pi number added.The device history record (dhr) for lot 5007u14qx was reviewed and no anomalies related to the reported issue were identified.The device was received for evaluation, and the reported issue was observed.A definitive root cause could not be determined.A rough pattern cut was detected on the sample.This pattern of burst probably could be caused by the usage of petroleum-based chemicals on the product.This chemical or lubricant is usually used by the doctor or nurse during handling the product while inserting the catheter into the patient.The use of petroleum derivatives, chemicals or lubricants will cause rubber deterioration.The instructions for use outline the correct way to use the catheter and how to avoid the type of damage observed on the device.This information will be used for tracking and trending purposes, and we will continue to monitor.

• 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: 22893947
• Report Number: 1423537-2025-00344
• Device Sequence Number: 12974827
• Product Code: KOD
• UDI-Device Identifier: 10192253026160
• UDI-Public: (01)10192253026160(17)300107(10)5007U14QX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/14/2025

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: 1621
• Device Catalogue Number: 1621
• Device Lot Number: 5007U14QX
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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