MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2-LUMEN: 5FR X 50CM W/ 80CM NITI; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-35052-HPHNM
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "rn noticed blood refluxing into white (proximal) lumen when aspirating and flushing pink (distal) lumen.Called infusion therapy for review.We found the same when aspirating and flushing suspected septum rupture so initiated picc removal." the patient's current condition is reported as "deceased".The device was not contributory to the patient's cause of death.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "rn noticed blood refluxing into white (proximal) lumen when aspirating and flushing pink (distal) lumen.Called infusion therapy for review.We found the same when aspirating and flushing suspected septum rupture so initiated picc removal." the patient's current condition is reported as "deceased".The device was not contributory to the patient's cause of death.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen catheter for evaluation.Signs of use in the form of biological material were observed on and within the catheter.Visual and microscopic inspection of the catheter revealed a hole in the portion of the proximal extension line molded within the juncture hub.The catheter body total length from juncture hub to the end of the distal tip measured at 19 15/16", which is within the specifications of 19 1/2"-20" per catheter product drawing.The outer diameter of the proximal extension line measured 0.094", which is within the specification limits of 0.093"-0.097" per proximal extension line extrusion drawing.The inner diameter of the proximal extension line measured 0.059", which is within the specification limits of 0.055"- 0.059" per proximal extension line extrusion drawing.The outer diameter of the distal extension line measured 0.094", which is within the specification limits of 0.093"-0.097" per distal extension line extrusion drawing.The inner diameter of the distal extension line measured 0.059", which is within the specification limits of 0.055"- 0.059" per distal extension line extrusion drawing.Each lumen was flushed using a lab inventory syringe filled with water.When the proximal lumen was flushed, water was observed entering the distal extension line and vice versa.Therefore, the customer report was replicated.The customer report of catheter lumen crossover was confirmed through complaint investigation of the returned sample.Visual and microscopic inspection of the catheter revealed a hole in the portion of the proximal extension line molded within the juncture hub.During functional testing, inter lumen crossover was observed between the proximal and distal lumens.The catheter met all relevant dimensional requirements.Based on the customer report and sample received, the probable root cause for this event is manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI PICC 2-LUMEN: 5FR X 50CM W/ 80CM NITI
• 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: 23245122
• Report Number: 9680794-2025-00824
• Device Sequence Number: 10195534
• Product Code: LJS
• UDI-Device Identifier: 00801902101099
• UDI-Public: (01)00801902101099(11)240708(17)260228(10)33F24F0290(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 33F24F0290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 50 KG