MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22854-E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "needle in the package was unable to aspirate".A new needle was used to complete the procedure.The patient had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however the customer provided one video and two photos for analysis.The photos and video show the introducer needle and the needle appeared unable to aspirate.The complaint of needle hub cracked was not able to be confirmed by the photos and video as the crack was not visible.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "alcohol , acetone, and polyethylene glycol can weaken the structure of polyurethane materials." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "needle in the package was unable to aspirate".A new needle was used to complete the procedure.The patient had no harm or injury.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 21305169
• Report Number: 9680794-2025-00104
• Device Sequence Number: 21058688
• Product Code: FOZ
• UDI-Device Identifier: 00801902111401
• UDI-Public: (01)00801902111401(11)240116(17)251116(10)71F24A0408(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K962577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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 Expiration Date: 11/16/2025
• Device Catalogue Number: CS-22854-E
• Device Lot Number: 71F24A0408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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; NOT REPORTED
• Patient Sex: Unknown