MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-42703-XP1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The photos show the catheter hub attached to the arrow raulerson syringe (ars).The catheter extrusion was separated adjacent to the hub, and the extrusion was not shown.The customer also returned the catheter hub for analysis.The catheter body was not returned.Signs of use in the form of biological material were observed on the sample.Visual and microscopic analysis of the catheter body at the hub revealed the separation point was rough and jagged.Clear residue consistent with dried medication was observed within the catheter.No customer response was provided regarding whether fluids were flushed through the catheter.The inner diameter of the catheter at the hub measured 0.039", which is within the specification limits of 0.039"-0.041" per catheter extrusion product drawing.Complete dimensional analysis, including the outer diameter, could not be performed without the separated portion of the catheter returned for analysis.Force was applied to the portion of the catheter extrusion that remained attached to the catheter hub to determine if the material was brittle.The material did not appear brittle to suggest a defect in the structural integrity of the material.The catheter k-05600-030b contained within catheter over needle assembly k-05600-024 can be used with an ars without complication.K-05600-030b is designed with an iso compliant female luer lock hub.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, "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 complaint of catheter separation was confirmed through investigation of the returned sample.Visual analysis revealed the catheter body was separated adjacent to the catheter hub and the separation point appeared rough and jagged.The separated catheter body was not returned.It was determined that manufacturing likely caused or contributed to the reported event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the catheter broke off from the base/tip with no resistance and could not be retrieved under the patient's skin." the catheter was removed by ir retrieval.There was no signs or symptoms after the event.The patient's current condition is reported as "stable and discharged home".

• Brand Name: ARROW PI CVC KIT: 3L 7 FR X 16 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23532416
• Report Number: 9680794-2025-00912
• Device Sequence Number: 9065915
• Product Code: FOZ
• UDI-Device Identifier: 10801902117080
• UDI-Public: (01)10801902117080(11)250123(17)260131(10)36F25A0006(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 36F25A0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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
• Patient Sex: Unknown