MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) CANNON II PLUS HEMODIALYSIS CATHETERIZATION KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number CS-15242-VSP

Device Problems Defective Device (2588); Gas/Air Leak (2946)

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

Event Date 05/25/2018

Event Type  malfunction  

Event Description

The patient came to the inu for a defective catheter.The dialysis catheter was pulling air and leaking where the white hub meets the tubing.The hub of the catheter was removed and a catheter repair kit was used to place a new hub on the dialysis catheter.Cat# : cs-15242-vsp; lot# : 23f17l0794.

• Brand Name: CANNON II PLUS HEMODIALYSIS CATHETERIZATION KIT
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 8013665
• MDR Text Key: 125296890
• Report Number: 8013665
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 23F17L0794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10950 DA