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

Model Number	2822
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
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 2 days of indwelling, the balloon deflated and the catheter came off from the urethra; period of use: 2 days.There was no patient injury.
Additional Manufacturer Narrative
Section d4: lot number, expiration date, unique identifier (udi) # has been updated.The device history record (dhr) for lot 3150u43qx was reviewed and no anomalies related to the reported issue were observed.A device was received for evaluation and a pinhole was found at the balloon edge area and not on the balloon itself.The root cause of the pinhole could be caused by the bubbles trapped in the latex and during the dipping process of latex layers and this bubble may have adhered to the catheter.A quality alert has been initiated, and manufacturing personnel were notified of this complaint for awareness.Based on this information, no corrective actions are warranted at this time 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 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: 22203953
• Report Number: 1423537-2025-00254
• Device Sequence Number: 17864354
• Product Code: KOD
• UDI-Device Identifier: 10192253026306
• UDI-Public: (01)10192253026306(17)280527(10)3150U43QX
• 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): 08/25/2025

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: 2822
• Device Catalogue Number: 2822
• Device Lot Number: 3150U43QX
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown