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

Catalog Number CAR-02800

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2019

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.

Manufacturer Narrative

(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 inside the extension lines.Visual examination of the returned sample revealed that the luer hubs on both extension lines were cracked.Microscopic examination revealed that the venous luer hub had two cracks and the arterial luer hub had one crack.Stress marks were also observed around the threaded portion of the luer hub.Hence, these cracks are consistent with over-tightening the luer hub.No other defects or anomalies were observed.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.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the 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 two cracks in the venous luer hub and one crack in the arterial luer hub.This cracks are consistent with damage due to over-tightening the luer hubs.A device history record review was performed based on sales history 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.

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.

• 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: 8362659
• MDR Text Key: 136897498
• Report Number: 1036844-2019-00128
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAR-02800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1