MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC NAVICURVE: 2L 5FR X 55CM W BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-35552-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l catheter for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the pink luer hub was separated from the extension line directly adjacent to one another.No anomalies were observed with the white luer hub and its respective extension line.Visual and microscopic analysis confirmed a portion of the extension line was still molded within the separated pink luer hub.The total length of the catheter extrusion measured 455mm, which is not within the specification limits of 55.86cm - 57.14cm per catheter product drawing.It was assumed that the catheter was intentionally trimmed approximately 10.36cm - 11.64cm.The trimmed portion was not returned.The separation between the proximal luer hub and extension line was measured at 73mm from the juncture hub.The outer diameter of the pink extension line measured 0.0954", which is within the specification limits of 0.093" - 0.097" per proximal extension line extrusion product drawing.The inner diameter of the proximal extension line measured 0.055", which is within the specification limits of 0.055" - 0.059" per proximal extension line extrusion product drawing.A device history record review was performed, and there was one potential finding.A non-conformance was initiated for 13c24g0409 in regard to extension line luer hub separation in use.The instructions for use (ifu) provided with this kit warns 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 extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual and microscopic analysis revealed the pink luer hub and its respective extension line was separated.A portion of the extension line was still molded within the separated luer hub.Based on the appearance of the damage, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported "a patient in a confused mental state grasped and separated an extension line hub from the extension." the catheter was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "stable".

• Brand Name: ARROW PI PICC NAVICURVE: 2L 5FR X 55CM W BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22951591
• Report Number: 9680794-2025-00741
• Device Sequence Number: 18608728
• Product Code: LJS
• UDI-Device Identifier: 10801902208764
• UDI-Public: (01)10801902208764(11)250109(17)260227(10)33F24K0346(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• 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
• Report Date (Section B): 08/07/2025

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: 02/27/2026
• Device Catalogue Number: DLX-35552-CURVB
• Device Lot Number: 33F24K0346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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