MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the luer-hub (brown) leakage at the junction." the user changed to a new set to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "the luer-hub(brown) leakage at the junction." the user changed to a new set to complete the procedure.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 provided two photos for analysis.The images show the catheter in its entirety and a close up to the distal brown extension line.No damage to the catheter or distal extension line were observed.The complaint of an extension line leak was not able to be confirmed by the photos.The customer also returned one 2-l catheter for analysis.Signs of use were observed in the form of biological material in the extension lines.The catheter was trimmed at the 10cm mark and both portions of the catheter body were returned.Microscopic examination did not reveal any abnormalities in the returned sample.The distal extension line outer diameter measured 0.085", which is within the specification limits of 0.084" - 0.088" per the proximal extension line extrusion product drawing.The distal extension line inner diameter measured 0.057", which is within the specification limits of 0.055" - 0.059" per the distal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to the extension line and flushed.The extension line was blocked by excess biological material.This blockage was removed using a guidewire, and the catheter flushed as normal.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." no leaks were detected from any portion of the extension lines or catheter.The returned catheter was then leak tested per bs en iso 10555-1 annex c (amrq-000071 rev15), which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter.A manual tug test confirmed that the extension line was secure within its hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of a leaking distal extension line was not confirmed through investigation of the returned sample or the customer supplied photos.The catheter was functionally leak tested in accordance with iso 10555 and no leaks were observed during functional testing.The catheter met all relevant visual, dimensional, and functional requirements.A device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned catheter.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 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: 24344237
• Report Number: 3006425876-2026-00187
• Device Sequence Number: 9674428
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)240228(17)290131(10)71F24B0756(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862056
• 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): 01/22/2026

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
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F24B0756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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