MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS

Catalog Number	VPS-0072-BPK
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "stylet was placed in a bd double lumen 4fr picc and picc was placed.After bbe was achieved they were pulling the stylet out of the picc and they noticed the tip of the vps stylet was split.The patient is fine and nothing fell off the stylet." 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).One vps g4 g1+ legacy stylet assembly was returned.A visual examination revealed one kink approximately 4 inches from the stylet housing.The visual examination also revealed the ecg wire is separated from the finished skived opening adhesive joint.The customer also provided a photograph.In the photograph, the ecg wire is separated from the finished skived opening adhesive joint.An analysis of the finished skived opening adhesive joint in the returned stylet revealed the presence of adhesive, indicating the ecg wire appears to have been properly located during stylet assembly at the manufacturing site.A device history record review performed on the stylet did not reveal any manufacturing related issues.An informal review of this information was conducted with representatives of the manufacturing site who concluded a probable cause of this issue could not be determined since it cannot be established when or how the coil wire was separated from the finished skived opening adhesive joint.No further actions are required at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARROW(R) VPS(R) ACCESS KIT
• Common Device Name: CATHETER, ULTRASOUND, INTRAVAS
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 22396505
• Report Number: 9680794-2025-00543
• Device Sequence Number: 20033631
• Product Code: OBJ
• UDI-Device Identifier: 10801902145779
• UDI-Public: (01)10801902145779(11)241206(17)260227(10)33F24L0007(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2025

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: VPS-0072-BPK
• Device Lot Number: 33F24L0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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