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

Catalog Number	K09T-12275B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges the pack was identified as having an open package on one side and the contents were no longer sterile.No additional patient consequence to report.

• 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: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20338624
• Report Number: 1125782-2024-00003
• Device Sequence Number: 12749062
• Product Code: OEZ
• UDI-Device Identifier: 00884450640500
• UDI-Public: 00884450640500
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2026
• Device Catalogue Number: K09T-12275B
• Device Lot Number: T3036884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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