MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CANNON II PLUS REPLACEMENT HUB SET; CHRONIC HEMODIALYSIS PRODUCTS

Catalog Number CAR-02400

Device Problem Crack (1135)

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

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported in (b)(6) 2016, a chronic hemodialysis catheter was successfully placed into the jugular vein of a female patient weighing (b)(6).The patient had hemodialysis treatment at a different hospital.When the hemodialysis was done at the end of (b)(6), there was a bubble in the hemodialysis pipeline and the device alarmed.The physician inspected and found a crack in the luer-lock cap.The physician replaced with a new extension tube for continued treatment.

• Brand Name: CANNON II PLUS REPLACEMENT HUB SET
• Type of Device: CHRONIC HEMODIALYSIS PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5744586
• MDR Text Key: 48017347
• Report Number: 1036844-2016-00335
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: CAR-02400
• Device Lot Number: 23F14F1348
• Other Device ID Number: 00801902031563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 56