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	01/17/2025
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 was inserted and the balloon was inflated per manufacturer instructions.At the time of catheter placement and balloon inflation, there was no resistance noted.Upon securing the foley catheter tubing to the patient's leg, the registered nurse (rn) noticed the foley catheter had fallen out.Upon inspection of the foley catheter and the balloon tip, it appeared that the balloon had popped.A new foley catheter was obtained and placed without incident.There was no injury to the patient involved.
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: 21374383
• Report Number: 1423537-2025-00077
• Device Sequence Number: 8549795
• Product Code: PPG
• UDI-Device Identifier: 10192253031850
• UDI-Public: (01)10192253031850(17)250901(10)2413400864
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: P4P16XSD
• Device Catalogue Number: P4P16XSD
• Device Lot Number: 2413400864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic