MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22123-F
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during insertion of the cvc when the physician tried to aspirate, he then noticed there was air escaping from the hub of the needle.Upon investigation of the introducer needle it was noticed that there is a crack on the needle hub.Another new cvc set opened to complete the procedure".The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned for evaluation; however, the customer provided one photo for analysis.The complaint of needle hub cracked was able to be confirmed by the photo.The photo shows a crack in the needle hub.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents' may also weaken the adhesive bond between catheter stabilization device and skin." the customer report of needle hub cracked was confirmed by visual inspection of the customer supplied photo.Visual analysis revealed a crack in 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 implemented using a new alcohol resistant material to manufacture the needle hub.The needle hub from this complaint was confirmed to be made from the old needle hub material.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during insertion of the cvc when the physician tried to aspirate, he then noticed there was air escaping from the hub of the needle.Upon investigation of the introducer needle it was noticed that there is a crack on the needle hub.Another new cvc set opened to complete the procedure".The patient had no harm or injury.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 21374125
• Report Number: 3006425876-2025-00154
• Device Sequence Number: 20969916
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: (01)00801902102188(11)240404(17)260304(10)71F24C1063(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: 03/04/2026
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F24C1063
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• 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