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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the luer hub/fitting has a crack during use on the patient.They changed to a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The complaint of a cracked arterial luer hub was able to be confirmed by the photos.The customer additionally provided photos of the connector assembly.No defects or anomalies were identified with the connector assembly.As no sample was returned for analysis, a complete visual inspection to determined the cause of the damage could not be performed.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs 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.
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the luer hub/fitting has a crack during use on the patient.They changed to a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.".

• 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: 20894367
• Report Number: 9680794-2024-01216
• Device Sequence Number: 12938969
• Product Code: NFK
• UDI-Device Identifier: 00801902096111
• UDI-Public: (01)00801902096111(11)230802(17)260630(10)33F23G0557(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): 11/15/2024

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: 06/30/2026
• Device Catalogue Number: CAR-02400
• Device Lot Number: 33F23G0557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown