MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 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 11/07/2023

Event Type  malfunction  

Event Description

It was reported that on 07 nov 2023, the doctor found the luer hub/fitting has crack during used on the patient.Patient was reported as fine post the procedure.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer report of a cracked luer hub was confirmed by complaint investigation of the returned sample.The customer returned one, opened hemodialysis kit for analysis.The connector assembly will be analysed as part of this complaint investigation.Definite signs of use were observed on the returned sample.Visual analysis revealed a crack on the arterial luer hub, adjacent to and on the threads.Multiple scratches were also observed.Microscopic examination confirmed the damage and revealed that the crack is consistent with repeated over tightening on the luer hubs.The connector assembly was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "flush catheter thoroughly with sterile normal saline for injection to remove residual blood, post-treatment and before instilling heparin".The arterial and venous lines were flushed with a lab inventory syringe, and the arterial line flushed as intended.A leak was observed at the location of the crack in the arterial luer hub.No leaks were observed when flushing the venous extension line.A manual tug test confirmed both luer hubs were secure to their respective extension lines.The 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." a device history record review was performed, and no relevant findings were identified.Based on the customer report and the condition of the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that"(b)(6) 2023, the doctor found the luer hub/fitting has crack during used on the patient.Patient was reported as fine post the procedure.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18245478
• MDR Text Key: 330567919
• Report Number: 9680794-2023-00935
• Device Sequence Number: 1
• Product Code: NFK
• UDI-Device Identifier: 00801902096111
• UDI-Public: 00801902096111
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2023
• 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