MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; URINARY DRAINAGE COLLECTION KIT

Model Number	P4P16XSD
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
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 balloon inflated per manufacturing instructions.No resistance was noted on inflation.The securement device did not work as catheter had fallen out.The balloon appeared to have popped.There was no harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2413400864 was reviewed and no anomalies related to the reported issue were observed.There were no photos or physical samples received for evaluation.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.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: URINARY DRAINAGE COLLECTION KIT
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21374157
• Report Number: 1423537-2025-00076
• Device Sequence Number: 8432246
• Product Code: PPG
• UDI-Device Identifier: 10192253031850
• UDI-Public: (01)10192253031850(17)250901(10)2413400864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: P4P16XSD
• Device Catalogue Number: P4P16XSD
• Device Lot Number: 2413400864
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/19/2025
• 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