MAUDE Adverse Event Report: ANGIODYNAMICS SCHON DUAL LUMEN; HEMODIALYSIS CATHETER

Model Number MHMD760

Device Problem Hole In Material (1293)

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

Event Date 08/16/2016

Event Type  Injury  

Event Description

A hole was found in the catheter once the patient was hooked up to dialysis.

• Brand Name: SCHON DUAL LUMEN
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS
• MDR Report Key: 6463341
• MDR Text Key: 72103156
• Report Number: MW5068931
• Device Sequence Number: 1
• Product Code: MSD
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHMD760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2017
• 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 Outcome(s): Required Intervention