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

Catalog Number CAR-02400

Device Problem Crack (1135)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that"10 jan 2024, the luer hub was found a crack during used on the patient.

Manufacturer Narrative

(b)(4).The report of a cracked luer hub was confirmed through complaint investigation of the returned sample.The customer returned one hem o dialysis connector assembly for evaluation.Signs-of-use were observed on the returned device.Visual inspection of the connector revealed the venous (blue) luer hub was cracked at the threads.This damage is consistent with repeated overtightening of the hubs during use.A lab inventory syringe filled with water was attached to the blue extension line and flushed.Water was observed leaking out of the crack on the blue venous luer hub's threads.The ifu provided with the kit informs the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "on (b)(6) 2024, the luer hub was found a crack during used on the patient.

• Brand Name: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18766106
• MDR Text Key: 336624470
• Report Number: 9680794-2024-00166
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CAR-02400
• Device Lot Number: 13F21L0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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