* HPF 300E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for * HPF 300E manufactured by Merit Medical Systems, Inc..

Event Text Entries

[51338] During ventriculography, the contrast media tubing came apart. Approx 9cc of a 39cc injection were infused. Ventriculagram was repeated with new tubing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 88950
• MDR Report Key: 88950
• Date Received: 1995-02-15
• Date of Report: 1994-09-30
• Date of Event: 1994-09-27
• Date Facility Aware: 1994-09-29
• Report Date: 1994-09-30
• Date Added to Maude: 1997-05-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: HIGH PRESSURE TUBING
• Product Code: ITY
• Date Received: 1995-02-15
• Model Number: *
• Catalog Number: HPF 300E
• Lot Number: 240060
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 87951
• Manufacturer: MERIT MEDICAL SYSTEMS, INC.
• Manufacturer Address: 79 WEST 4500 SOUTH SUITE 9 SALT LAKE CITY UT 841072649 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1995-02-15