MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; CATHETER, RETENTION TYPE, BALLOON

Model Number	8887605205
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Per customer, he was very unsatisfied with the catheters he had purchased, he normally uses those, and everything was fine.This time he said, he was having an issue with the flow, and he ended up in the hospital.Additional information was received from the customer and stated that the urine flow would not flow into the bag, it would bypass the catheter.There was no medical intervention or treatment required as the result of the reported incident.
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.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.Emdr section h6 (health effect - impact code) has been updated to include 4629 device revision or replacement.
Event or Problem Description
Per customer, he was very unsatisfied with the catheters he had purchased, he normally uses those, and everything was fine.This time he said, he was having an issue with the flow, and he ended up in the hospital.Additional information was received from the customer and stated that the urine flow would not flow into the bag, it would bypass the catheter.There was no medical intervention or treatment required as the result of the reported incident.On (b)(6) 2024, additional information was received from the customer and stated that the patient went to emergency only to have the catheter changed.
Additional Manufacturer Narrative
The device history record (dhr) for 2305510 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.Seven unused, sealed samples were received for evaluation.Upon inspection, the reported issue was not confirmed, and the root cause of the reported event cannot be identified to be related to the manufacturing process.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: CATHETER, RETENTION TYPE, BALLOON
• 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: 20135053
• Report Number: 1423537-2024-00143
• Device Sequence Number: 12568067
• Product Code: EZL
• UDI-Device Identifier: 10884521016798
• UDI-Public: (01)10884521016798(17)280131(10)2305510
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024010
• 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,Followup
• Report Date (Section B): 11/18/2024

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: 8887605205
• Device Catalogue Number: 8887605205
• Device Lot Number: 2305510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/10/2024; 09/13/2024; 11/18/2024
• 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