MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ARTERIAL CATHETER MINI KIT; PLASTIC SURGERY AND ACCESSORIES KIT

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2021

Event Type  Injury  

Event Description

The patient had the right brachial arterial line placed the morning for a procedure.This was used intraop with no issues.The patient was taken to his room post procedure and the dressing was noted to be saturated.As the dressing was being removed, the hub was found to be disconnected from the remnant part of the catheter.

• Brand Name: ARTERIAL CATHETER MINI KIT
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 11398281
• MDR Text Key: 234235008
• Report Number: 11398281
• Device Sequence Number: 1
• Product Code: FTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention