MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC VAMP; CATHETER, CONTINUOUS FLUSH

Model Number 48VMP120

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

Vamp product utilized after arterial line insertion.Tubing separated from connection luer lock at end closest to patient.Fda safety report id# (b)(4).

• Brand Name: VAMP
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 11966118
• MDR Text Key: 255449987
• Report Number: MW5101777
• Device Sequence Number: 1
• Product Code: KRA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: 48VMP120
• Device Catalogue Number: 48VMP120
• Device Lot Number: 63347877
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR