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

Catalog Number CAR-02800

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported during dialysis blood was coming through the blue port hub.On inspection it had a large longitudinal crack from where cap fastens to the bulb area.The hub was changed with a hub repair kit.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported during dialysis blood was coming through the blue port hub.On inspection it had a large longitudinal crack from where cap fastens to the bulb area.The hub was changed with a hub repair kit.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer provided two photos and a video for analysis.The complaint of luer hub/fitting has crack was able to be confirmed by the photos and video.The two photos revealed a crack that runs the length of the blue luer hub.The video revealed the same crack in use which resulted in leaking.A complete visual inspection could not be performed as no sample was returned for analysis.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 instructions for use (ifu) provided with this kit warns the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Type of Device: KIT, REPAIR, CATHETER, HEMODI
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16855971
• MDR Text Key: 314414210
• Report Number: 9680794-2023-00317
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K020430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.