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

Model Number 00884450620120

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2022

Event Type  malfunction  

Event 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®
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 15469995
• MDR Text Key: 300444372
• Report Number: 15469995
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 00884450620120
• UDI-Public: (01)00884450620120
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 108 KG