MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROW CANON II DIALYSIS CATH

Model Number CS-15322-VSP

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/30/2018

Event Type  Injury  

Event Description

The catheter was placed, use after placement revealed a leak at the hub.The pt required surgical intervention to repair and replace the catheter.Dates of use: (b)(6) 2018 - (b)(6) 2018.Diagnosis or reason for use: end stage renal disease.

• Brand Name: ARROW CANON II DIALYSIS CATH
• Type of Device: DIALYSIS CATH
• Manufacturer (Section D): ARROW INTERNATIONAL
• MDR Report Key: 7665730
• MDR Text Key: 113397275
• Report Number: MW5078256
• Device Sequence Number: 1
• Product Code: MPB
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS-15322-VSP
• Device Catalogue Number: CS-15322-VSP
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR