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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
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 foley catheter balloon has popped inside the patient (while foley in situ) 3 times in a row.The two occurrences happened within 36 hours.The patient could feel the balloon pop and then foley falls out.Per customer, on the packing for this product it states 5ml 2 way retention; however, on the foley catheter itself it reads "inflate w/10mls' on the balloon port.The last 3 times when the balloon popped, the nurses had instilled 10 mls into the balloon and this time after reviewing the packaging further they instilled 5 mls into the balloon.However, they were unable to see if the last catheter balloon would pop because the physician ordered the foley out.There was no patient harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2317748 was reviewed and no anomalies related to the reported issue were observed.The physical device was received for evaluation; however, visual and functional inspection cannot be performed since only tip of the catheter was returned (incomplete sample returned).Therefore, the reported condition was not confirmed.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• 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; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22065049
• Report Number: 1423537-2025-00207
• Device Sequence Number: 7849017
• Product Code: FCM
• UDI-Device Identifier: 10884521016668
• UDI-Public: (01)10884521016668(17)280531(10)2317748
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/27/2025

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: 8887605148
• Device Catalogue Number: 8887605148
• Device Lot Number: 2317748
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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