MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45703-XP1A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "central line placed in pt on arrival.About an hour after placement, blue infusion port became disconnected at the cap with little force when attempting to withdraw plunger.This left the iv line open with nothing being able to seal the line.Line clamped and physician notified of defect." 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).
Event or Problem Description
It was reported that "central line placed in pt on arrival.About an hour after placement, blue infusion port became disconnected at the cap with little force when attempting to withdraw plunger.This left the iv line open with nothing being able to seal the line.Line clamped and physician notified of defect." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one medial(blue) luer hub, with adapter attached, for analysis.The extension line was not attached to the extension line and was not returned by the customer.Visual inspection of the returned.Device revealed that the medial extension line was separated, and no portion of the extension line extrusion was visible.The luer hub was severed in half to inspect the inner diameter of the distal opening.Microscopic analysis confirmed no portion of the extension line material was still visible inside the separated luer hub.The medial extension line was not returned by the customer and therefore dimensional inspection could not be performed.Manufacturing was contacted and they confirmed this is a manufacturing defect due to incorrect placement of the rod used to mold the extrusion in the hub.Manufacturing confirmed further analysis by the manufacturing site will be required to investigate this defect.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, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the report of an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the medial extension line had separated adjacent to the luer hub.It was observed that no portions of the molding were visible inside the luer hub.Based on the analysis of the returned sample , manufacturing caused or contributed to the reported event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend complaints of this nature.

• Brand Name: ARROW PI CVC KIT: 3L 7 FR X 20 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24036769
• Report Number: 9680794-2026-00057
• Device Sequence Number: 9074957
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: (01)20801902117216(11)250224(17)260228(10)36F25B0046(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 36F25B0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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