MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX40CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-34041-HPHNM
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "picc was placed by consultant radiologist in prc radiology department on (b)(6) 2025.Device was being used to administer immunotherapy via electronic infusion device.On (b)(6) 2025 it was noted by ward staff during flushing of line as per daily line check protocol that saline flush was leaking from catheter extension.Catheter was clamped distal to fixation wing but before leak point on the extension.Iv team were notified and line was removed from patient." 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).The customer provided one image showing the kit sticker label.The customer also returned one single-lumen, pressure-injectable (pi) picc for analysis.Signs of use in the form of biological material were observed inside the catheter.After failing functional testing, a small hole was observed on the extension line extrusion.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The appearance of the hole is consistent with contact with a sharp object (i.E.Needle, scalpel, sutures, etc.).The extension line outer diameter measured 0.095", which is within the specification limits of 0.093"-0.097" per the extension line extrusion product drawing.The extension line inner diameter measured 0.057", which is within the specification limits of 0.055"-0.059" per the extension line extrusion product drawing.A lab inventory syringe filled with water was attached to the extension line and flushed.Water was observed leaking from the hole on the extension line.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 report of a leaking extension line was confirmed through analysis of the returned sample.Visual and functional analysis revealed a leak from a cut on the extension line extrusion.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The appearance of the hole is consistent with contact with a sharp object (i.E.Needle, scalpel, sutures, etc.).Despite the damage, the sample met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "picc was placed by consultant radiologist in prc radiology department on (b)(6) 2025.Device was being used to administer immunotherapy via electronic infusion device.On (b)(6) 2025 it was noted by ward staff during flushing of line as per daily line check protocol that saline flush was leaking from catheter extension.Catheter was clamped distal to fixation wing but before leak point on the extension.Iv team were notified and line was removed from patient." 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 4FRX40CM 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: 24090333
• Report Number: 9680794-2026-00006
• Device Sequence Number: 18703058
• Product Code: LJS
• UDI-Device Identifier: 00801902100931
• UDI-Public: (01)00801902100931(11)250327(17)270228(10)33S25G0800(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): 12/23/2025

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 Catalogue Number: PR-34041-HPHNM
• Device Lot Number: 33S25G0800
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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