MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-42703-XPCN1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "no deviation from hospital standpoint.Equipment was broken in the packaging from manufacturer." this was found during inspection.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The customer returned a guide wire within its advancer for analysis.No obvious signs of use were observed on the device.The guide wire cap and kit packaging were not returned.Visual examination revealed the coil wire on the distal j-bend of the guide wire was kinked and the core wire was exposed.Microscopic examination revealed that both welds were full and spherical.Both welds were attached to the core wire.The overall length of the guide wire measured 604 mm, which is within the specification limits of 600-608 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.793 mm, which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe [ars] approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through a lab inventory ars and 18ga introducer needle to functionally test the guide wire.The guide wire passed through with little to no resistance.A manual tug test confirmed the distal and proximal welds were fully secured and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user , "do not use if package is damaged." the report that the guide wire was kinked was confirmed through complaint investigation of the returned sample.A kink was observed on the distal j-bend of the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.During normal assembly, the kinked portion of the guide wire would be protected within the guide wire cap of the advancer assembly.A device history record review was performed, and no relevant findings were identified.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "no deviation from hospital standpoint.Equipment was broken in the packaging from manufacturer." this was found during inspection.There was no patient involvement.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• 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: 22123408
• Report Number: 9680794-2025-00496
• Device Sequence Number: 7266322
• Product Code: FOZ
• UDI-Device Identifier: 10801902162080
• UDI-Public: (01)10801902162080(11)250113(17)260820(10)33F24M0024(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 05/29/2025

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: 08/20/2026
• Device Catalogue Number: CDC-42703-XPCN1A
• Device Lot Number: 33F24M0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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.; NOT REPORTED.
• Patient Sex: Unknown