MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT/LOW PROFILE; LIFEPORT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

Lifeport explanted due to malfunction/hole in either diaphragm or catheter.This lifeport was kept in operating room manager's office for unknown period of time without identifiers.There have been several other reports of malfunctioning lifeports within this hospital system, so a "john doe" report is being generated for the purpose of reporting.

• Brand Name: SMART PORT/LOW PROFILE
• Type of Device: LIFEPORT
• Manufacturer (Section D): ANGIODYNAMICS; latham NY
• MDR Report Key: 4640367
• MDR Text Key: 5613880
• Report Number: MW5041634
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other