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 01/31/2024

Event Type  malfunction  

Event Description

It was reported that: "(b)(6) 2024, the luer hub was found cracked during use on the patient.The patient was reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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".A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "10 jan 2024, the luer hub was found cracked during use on the patient.The patient was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened kit with the connector assembly for analysis.Definite signs of use were observed.Visual analysis revealed numerous cracks on both arterial and venous luer hubs, adjacent to and on the threads.Multiple scratches were also observed.Microscopic examination confirmed the damage and revealed that the cracks are consistent with repeated over tightening on the luer hubs.It was additionally noted that the color on both luer hubs was drastically faded.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 small leak was observed at the location of the crack in the arterial luer hub.A manual tug test confirmed both extension lines were secure to their respective luer hubs.A device history record review was performed, and no relevant findings were identified.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." the customer report of a cracked luer hub was confirmed by complaint investigation of the returned sample.Visual and functional inspections revealed that both arterial and venous luer hubs were cracked.The appearance of the cracks was consistent with over-tightening on the luer hub.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) 2024, the luer hub was found cracked during use on the patient.The patient was reported as fine.

• 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 INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18814640
• MDR Text Key: 337637159
• Report Number: 9680794-2024-00150
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; NOT REPORTED