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

Catalog Number	CAR-02400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the doctor found the luer hub damaged during use on the patient." the user changed to a new set.There was no medical intervention required.The patient's condition is reported as "fine".
Event or Problem Description
It was reported "the doctor found the luer hub damaged during use on the patient." the user changed to a new set.There was no medical intervention required.The patient's condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one connector assembly for analysis.It was noted that the compression fitting, the green sleeve, and a section of the catheter body were fixed to the juncture hub of the connector assembly.Signs of use were observed.Visual analysis revealed the red arterial luer hub and the blue venous luer hub contained a crack.Stress marks were also noted around the threads.Microscopic examination confirmed the damage.The appearance of this damage is consistent with overtightening or repeated tightening of the hubs.No defects or anomalies were observed on any other portion of the returned device.Both luer connections were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "establish and maintain catheter patency.Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy".A lab inventory syringe filled with water was used to flush each extension line.When flushing both the venous and arterial extension line, water was observed leaking from the cracks.A manual tug test confirmed both luer hub were securely attached to the respective lumens.A device history record review was performed, and no relevant findings were identified.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".The report of a cracked luer hub was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the red arterial and the blue venous luer hubs contained a crack and damage consistent with overtightening or repeated tightening of the hubs.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.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Common Device Name: 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: 20127710
• Report Number: 9680794-2024-00852
• Device Sequence Number: 3101628
• Product Code: NFK
• UDI-Device Identifier: 00801902096111
• UDI-Public: (01)00801902096111(11)230330(17)260228(10)33F23C0882(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: CAR-02400
• Device Lot Number: 33F23C0882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown