MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number	IPN918781
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the cvc was replaced with a guidewire.A new 5fr 13cm, 2-lumen cvc was placed.I noticed, when testing it, that air came out of the proximal lumen when aspirating." the cvc was removed and replaced.There was no medical intervention required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the cvc was replaced with a guidewire.A new 5fr 13cm, 2-lumen cvc was placed.I noticed, when testing it, that air came out of the proximal lumen when aspirating." the cvc was removed and replaced.There was no medical intervention required.
Additional Manufacturer Narrative
Qn#(b)(4).Additional information received from the customer indicates the condition of the patient is "fine".The actual device was not returned; however, the customer provided two photos for analysis.The complaint of an air aspiration was able to be confirmed by the photos.The photos show two syringes attached to the distal and proximal lumens after aspiration.Air bubbles can be seen in the syringe attached to the proximal lumen.No defects or anomalies are observed on the distal lumen.The air aspiration can be confirmed based on the photos, however, a complete visual inspection to determine the cause could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." 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.

• Brand Name: ARROW CVC SET: 2L 5 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: 23451436
• Report Number: 3006425876-2025-01081
• Device Sequence Number: 8056624
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)250116(17)291231(10)71F25A0355(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 10/06/2025

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 Model Number: IPN918781
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F25A0355
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2025
• 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