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	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after the procedure, the catheter balloon popped within patient bladder.The patient required urology follow-up and a new catheter has been placed (additional procedural time and costs).Additional information was received from the customer and stated that the balloon broke however there was a query if all the pieces were dispelled.Per customer, the patient felt a pop.A urology consultation with an ultrasound and ct confirmed that no retained pieces was left inside the patient.A new foley was placed without any issues.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• 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, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20091274
• Report Number: 1423537-2024-00140
• Device Sequence Number: 20767426
• Product Code: FCM
• UDI-Device Identifier: 10884521016668
• UDI-Public: (01)10884521016668(17)280630(10)2318415
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 2318415
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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