MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "(b)(6) 2024, the doctor found needle hub leak 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).The customer returned one 18 ga introducer needle for analysis.No signs of use were observed on the needle.Visual analysis of the needle revealed a vertical crack in the needle hub.The introducer needle was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "insert introducer needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the returned 18 ga introducer needle was attached to a lab inventory arrow raulerson syringe (ars).The ars was unable to draw and aspirate water.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 a cracked needle hub was confirmed by complaint investigation.Visual analysis revealed a crack in the needle hub.During functional testing, a lab inventory ars could not properly draw and aspirate water with the returned needle attached.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.A capa was implemented using a new alcohol resistant material to manufacture the needle hub.The reported needle hub 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 "on (b)(6) 2024, the doctor found needle hub leak 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: 5 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 23597155
• Report Number: 3006425876-2025-01063
• Device Sequence Number: 18737020
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)241209(17)291130(10)71F24M0218(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• 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): 10/24/2025

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 Catalogue Number: ES-04301
• Device Lot Number: 71F24M0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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