MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND CUSTOM CARDIOVASCULAR KIT; CARDIOVASCULAR PROCEDURE KIT

Catalog Number	K09T-01138
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the device arrived with a break in the seal of the packaging.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect medical device has been returned for evaluation.The complaint was confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: CUSTOM CARDIOVASCULAR KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22091828
• Report Number: 1125782-2025-00007
• Device Sequence Number: 6947676
• Product Code: OEZ
• UDI-Device Identifier: 00884450336007
• UDI-Public: 00884450336007
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Expiration Date: 03/12/2026
• Device Catalogue Number: K09T-01138
• Device Lot Number: T3148676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown