MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SI-11142
Medical Device Problem Codes	Dull, Blunt (2407); Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "an attempt is made to insert a mac high-flow catheter, but it did not penetrate the skin and bends due to the flexible, non-rigid material, despite dilation." good faith efforts were made to obtain additional information regarding the reported device issue and to assess whether any patient harm, injury, or adverse health consequences occurred.A total of three documented attempts were made to contact the customer; however, no response or additional information was received.As a result, further evaluation of device performance and patient impact could not be completed based on the information available.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 24958424
• Report Number: 9680794-2026-00309
• Device Sequence Number: 10084770
• Product Code: OFC
• UDI-Device Identifier: 10801902207095
• UDI-Public: (01)10801902207095(11)251021(17)300930(10)14F25K0164(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K002507
• 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): 03/31/2026

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 Catalogue Number: SI-11142
• Device Lot Number: 14F25K0164
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2025
• 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