MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "within 5 days pt presented with arm swelling.Confirmation via ultrasound that pt developed dvt.Inserted by radio logist on left side, unknown vessel.Caj tip placement.4 cm external length.Flucloxacillin infused.Pt still has line inserted." the hematology doctor was called to advise for treatment.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).
Additional Manufacturer Narrative
(b)(4) the catheter returned one, single-lumen pi picc for analysis.No signs of use were observed on the returned catheter.It was confirmed that the returned catheter is a representative sample.No defects or anomalies were observed on the returned sample.The catheter body length measured 19 3/4", which is within the specification limits of 19 1/2" - 20" per catheter product drawing.The outer diameter of the catheter body measured 0.056", which is within the specification limits of 0.054" - 0.057" per catheter body extrusion product drawing.The catheter was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the returned catheter was flushed with water using a lab inventory syringe.No resistance or blockages were met, therefore, the distal lumen flush as intended.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "the pressure injectable picc is contraindicated wherever there is presence of device related infections or presence of thrombosis in the intended insertion vessel or catheter pathway.Clinical assessment of the patient must be completed to ensure no contraindications exist." the customer report of a catheter related thrombosis could not be confirmed by investigation of the returned sample.The customer returned a representative sample; however, the reported device was not returned.The returned catheter met all relevant visual, dimensional, and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the root cause cannot be determined at this time without the reported catheter returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "within 5 days pt presented with arm swelling.Confirmation via ultrasound that pt developed dvt.Inserted by radiologist on left side, unknown vessel.Caj tip placement.4 cm external length.Flucloxacillin infused.Pt still has line inserted." the hematology doctor was called to advise for treatment.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 24454708
• Report Number: 9680794-2026-00141
• Device Sequence Number: 18643747
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: (01)00801902101051(11)250401(17)270331(10)33F25A0445(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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: PR-35041-HPHNM
• Device Lot Number: 33F25A0445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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