MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CUSTOM HEART CATH KIT; CUSTOM KIT

Catalog Number	K09T-14106A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
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 packaging seals are arriving broken.
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 3 similar complaints for this lot number were identified.

• Brand Name: CUSTOM HEART CATH KIT
• Common Device Name: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 901 moorefield park dr; #103; north chesterfield VA 23236
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 901 moorefield park dr; #103; north chesterfield VA 23236
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22099411
• Report Number: 1125782-2025-00008
• Device Sequence Number: 8526628
• Product Code: OEZ
• UDI-Device Identifier: 00884450851586
• UDI-Public: 00884450851586
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: K09T-14106A
• Device Lot Number: `
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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