MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI

Catalog Number CAR-02800

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports a leak in the hub of the device.The hub started to aspirate air during dialysis.The device was replaced.

Event Description

The customer reports a leak in the hub of the device.The hub started to aspirate air during dialysis.The device was replaced.

Manufacturer Narrative

Qn# (b)(4).The customer returned one connector assembly for evaluation.The catheter body was not returned.The sample contained signs of use in the form of biological material in returned sample revealed that the luer hubs on both extension lines were cracked.Circular stress marks were also observed around the threaded portion of the luer hub, indicating that over-tightening or excessive torque caused the damage.The connector assembly was leak tested by attaching a 5 ml lab syringe filled with water to each luer hub and depressing the plunger.Water was observed leaking out of the cracks on both luer hubs.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user , "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".The customer report of a cracked luer hub was confirmed by complaint investigation.Visual inspection revealed cracks in the venous and arterial luer hubs.This damage is consistent with over-tightening the luer hubs.A device history record review was performed with no relevant findings.Based the sample received and the customer description , it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Type of Device: KIT, REPAIR, CATHETER, HEMODI
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8428179
• MDR Text Key: 139059332
• Report Number: 1036844-2019-00253
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• PMA/PMN Number: K020430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CAR-02800
• Device Lot Number: 23F17G0445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1