MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918764
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during insertion it was impossible to flush the medial line.The catheter was replaced by a different one." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".
Event or Problem Description
It was reported that "during insertion it was impossible to flush the medial line.The catheter was replaced by a different one." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen catheter for analysis.Signs of use were observed on the catheter body.No defects or anomalies were observed.The overall length of the catheter body measured 217mm, which is within the specification limits of 207mm - 227mm per the catheter product drawing.The catheter outer diameter measured 2.46mm, which is within the specification limits of 2.39mm - 2.49mm per the catheter body extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.Water was observed exiting the designated locations towards the distal end.No blockages or resistance was observed.Performed per ifu statement, "flush lumen(s) to completely clear blood from catheter." functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "if using standard arrow advancer, raise thumb and pull arrow advancer approximately 4 - 8 cm away from arrow raulerson syringe or introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into syringe barrel to further advance guidewire.Continue until guidewire reaches desired depth".A lab inventory guidewire (0.81mm) was passed through the distal lumen of the returned catheter.The guidewire was able to advance with no resistance.A manual tug test confirmed the luer hubs were securely attached to the extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed." the customer report of catheter blocked during use could not be confirmed by investigation of the returned sample.Visual and dimensional analysis did not identify any defects or anomalies that would suggest a manufacturing-related issue.Functional inspection revealed that no resistance was experienced when flushed.Based on the customer report and the sample received, no problem was found.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 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: 24607706
• Report Number: 3006425876-2026-00295
• Device Sequence Number: 10224921
• Product Code: DQY
• UDI-Device Identifier: 10801902105339
• UDI-Public: (01)10801902105339(11)250520(17)290930(10)71F25E0273(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: IPN918764
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F25E0273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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