MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI JACC KIT: 2-L 5.5 FR X 25 CM CG+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42552-JX1A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "catheter was originally inserted on (b)(6) 2025.Removed (b)(6) 2025 due to extension line leaking.Patient noticed pink distal lumen leaking when flushing the catheter.Leak noticed where clear extension tubing meets the pink port.Line exchanged needed.This was originally a tunneled line.Replacement line was tunneled as well." 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).
Event or Problem Description
It was reported "catheter was originally inserted on (b)(6) 2025.Removed (b)(6) 2025 due to extension line leaking.Patient noticed pink distal lumen leaking when flushing the catheter.Leak noticed where clear extension tubing meets the pink port.Line exchanged needed.This was originally a tunneled line.Replacement line was tunneled as well." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one 2-l catheter for analysis.Definite evidence of use was observed on the returned catheter.Visual and microscopic analysis revealed that the distal extension line contained a hole directly adjacent to the luer hub.A portion of the extrusion was still molded within the luer hub.This damage is consistent with a manufacturing molding defect.The outer diameter of the distal extension line measured 0.0941 , which is within the specification limits of 0.093" - 0.097" per the extension line extrusion product drawing.The inner diameter measured 0.056", which is within the specification limits of 0.055" - 0.059" per the extension line extrusion product drawing.The catheter was functionally tested per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." leaking was observed from the proximal end of the distal lumen.Visual analysis revealed a hole in the extrusion.The proximal extension line flushed as intended with no signs of leaking.A manual tug test confirmed that both extension lines were secure with their respective luer hubs.A device history record review was performed, and there was one potential finding.A non-conformance was initiated for 13c23f0687 in regard to extension line leak during use.The ifu provided with this kit instructs 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 complaint investigation of the returned sample.Visual analysis revealed a hole in the distal extension line directly adjacent to the luer hub.Dimensional analysis revealed that the extension line inner and outer diameters measured within specification.Based on the customer report and the sample received, the root cause of this issue is manufacturing related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI JACC KIT: 2-L 5.5 FR X 25 CM CG+
• 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: 21977449
• Report Number: 9680794-2025-00398
• Device Sequence Number: 9197425
• Product Code: LJS
• UDI-Device Identifier: 50801902123904
• UDI-Public: (01)50801902123904(11)231019(17)250228(10)33F23K0167(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153423
• 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,Followup
• Report Date (Section B): 04/17/2025

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
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: CDC-42552-JX1A
• Device Lot Number: 33F23K0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: Female