MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS CATHETER DIALYSIS SCHON 14F X 15; CATHETER, SUBCLAVIAN

Catalog Number 10800701

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/18/2019

Event Type  malfunction  

Event Description

Vascath was not functioning properly.One of the ports broke and they were not able to use the line.The pt had to undergo an unnecessary add'l procedure to replace the wire with a new one.Fda safety report id# (b)(4).

• Brand Name: ANGIODYNAMICS CATHETER DIALYSIS SCHON 14F X 15
• Type of Device: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): ANGIODYNAMICS; latham NY
• MDR Report Key: 9348862
• MDR Text Key: 167333833
• Report Number: MW5091189
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10800701
• Was Device Available for Evaluation?: No
• 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