MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MEDICAL®; CARDIOVASCULAR PROCEDURE KIT

Model Number	00884450620120
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Merit medical custom manifolds have been noted to have an issue with the bonding causing the fluid to leak and the manifolds to crack.

• Brand Name: MERIT MEDICAL®
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 15469995
• Report Number: 15469995
• Device Sequence Number: 17260456
• Product Code: OEZ
• UDI-Device Identifier: 00884450620120
• UDI-Public: (01)00884450620120
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/15/2022
• Report Date (Section F): 09/15/2022

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: 00884450620120
• Device Catalogue Number: K09-13857
• Device Lot Number: H2448886
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 108 KG
• Date Report Sent to FDA: 09/15/2022