MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45563-CURVC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one, 3-lumen picc catheter for analysis.Signs of use were observed inside the extension line.Initial analysis revealed that the catheter body was severed.The severed portion was not returned for analysis.It is assumed that the sample was intentionally cut by the customer.Visual analysis confirmed that the proximal extension line was separated.The separated portion of the extension line (including the luer hub) was not returned.Microscopic examination confirmed the separation; however, a full analysis could not be performed on the separated portion of extension line.The extension line outer diameter 0.0955", which is within the specification limits of 0.0930"-0.0970" per the proximal extension line product drawing.The inner diameter at the point of separation measured 0.057", which is within the specification limits of 0.055"-0.059" per the proximal extension line product drawing.Functional inspection could not be performed due to the nature of the damaged on returned sample.A manual tug test confirmed that the medial and distal extension lines was secure within the luer hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The ifu also states, "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 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 separated extension line was confirmed through analysis of the returned sample.Visual analysis revealed that the proximal line was separated.Despite the damage, the sample met all dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from the manufacturing site, the likely root cause is manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "white hub came off picc".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM TCG
• 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: 24545946
• Report Number: 9680794-2026-00164
• Device Sequence Number: 9377993
• Product Code: LJS
• UDI-Device Identifier: 10801902208740
• UDI-Public: (01)10801902208740(11)251014(17)261101(10)33F25G0394(21)
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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 Catalogue Number: DLX-45563-CURVC
• Device Lot Number: 33F25G0394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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