MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	00884450009222
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We have a 5 french impress bert catheter that would not flush, so i don't know if there's just not a hole or what.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan UT 84095
• MDR Report Key: 16466912
• Report Number: 16466912
• Device Sequence Number: 7671945
• Product Code: DQO
• UDI-Device Identifier: 00884450009222
• UDI-Public: (01)00884450009222(01)00884450009222(17)230317(10)E1805173
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2023
• Report Date (Section F): 02/02/2023

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: Other
• Device Model Number: 00884450009222
• Device Catalogue Number: 510038VER
• Device Lot Number: E1805173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2023
• 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: 86 KG
• Date Report Sent to FDA: 02/02/2023