MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, INTRAVASCULAR, THERAPEUTIC

Device Problem Flushing Problem (1252)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

The double lumen 3.5 french uvc line prepped to insert.The nicu rn was unable to flush secondary port.A new double lumen was obtained and flushed without difficulty.The report submitted for tracking purposes.

• Brand Name: ARGYLE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): COVIDIEN; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 9314546
• MDR Text Key: 166180925
• Report Number: 9314546
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2019
• Date Report to Manufacturer: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1