MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8IN (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-24301-E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "(b)(6) 2025, the doctor found the needle hub has crack during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The image shows various components from the cvc kit including the introducer needle.The complaint of a cracked needle hub was not able to be confirmed by the photo.The customer also returned an introducer needle, 2 other needles, guidewire assembly, catheter, and dilator for analysis.Signs of use in the form of biological material were observed on the needle.Visual analysis revealed that the needle hub contained one crack on the hub.Microscopic examination confirmed the crack.It was noted that the needle hub contains a notch.A device history record review was performed, and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through investigation of the returned sample.Visual inspection revealed a crack on the needle hub.The failure mode identified is consistent with the failure mode investigated per a previously opened capa.Based on the capa investigation, the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.The capa was fully implemented 23-aug-2023 using a new alcohol-resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint occurred prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2025, the doctor found the needle hub has crack during use on the patient." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 16 GA X 8IN (20 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23606153
• Report Number: 3006425876-2025-01090
• Device Sequence Number: 9259323
• Product Code: FOZ
• UDI-Device Identifier: 00801902102225
• UDI-Public: (01)00801902102225(11)240912(17)260827(10)71F24J0327(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: 08/27/2026
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F24J0327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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