MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DOVER; URINARY DRAINAGE COLLECTION KIT

Model Number	6070
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
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 item inside the kit was faulty.According to the customer, when they inserted liquid into the balloon, it leaked.There was no harm reported.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2416314564 was reviewed and no anomalies related to the reported issue were observed.A picture and a video were provided for analysis, and upon review, the reported issue was observed.The affected component is produced by an external supplier.Per supplier investigation, a definitive root cause could not be determined, as the physical device was not returned for evaluation.Based on this information, no corrective actions are warranted at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: DOVER
• Common Device Name: URINARY DRAINAGE COLLECTION KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 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: 23573762
• Report Number: 1423537-2025-00462
• Device Sequence Number: 10178716
• Product Code: PPG
• UDI-Device Identifier: 10884521156937
• UDI-Public: (01)10884521156937(17)260301(10)2416314564
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Expiration Date: 03/01/2026
• Device Model Number: 6070
• Device Catalogue Number: 6070
• Device Lot Number: 2416314564
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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