MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-45703-XPCN1A
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during central line placement, introducer needle was inserted under us guidance.When i went to pullback on the syringe, i got air bubbles mixed with blood return.After removing the needle, attempted to flush the needle and the syringe with normal saline.I had a similar finding, with air bubbles in the syringe.When flushing the saline out, fluid was expelled out the side of the needle hub, revealing a hole within the needle hub that could inappropriately introduce air into the closed system.The needle was discarded and a new cvc kit was opened.Procedure was completed with no complications to the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for evaluation.Visual, dimensional, and functional inspections were not conducted due to the absence of a returned device.No additional testing was performed.A review of the device history record was conducted, and no relevant manufacturing or quality issues were identified.Based on the available information, the complaint could not be confirmed.The root cause could not be determined due to the lack of a returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during central line placement, introducer needle was inserted under us guidance.When i went to pullback on the syringe, i got air bubbles mixed with blood return.After removing the needle, attempted to flush the needle and the syringe with normal saline.I had a similar finding, with air bubbles in the syringe.When flushing the saline out, fluid was expelled out the side of the needle hub, revealing a hole within the needle hub that could inappropriately introduce air into the closed system.The needle was discarded and a new cvc kit was opened.Procedure was completed with no complications to the patient." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24568351
• Report Number: 9680794-2026-00176
• Device Sequence Number: 21190797
• Product Code: FOZ
• UDI-Device Identifier: 10801902161243
• UDI-Public: (01)10801902161243(11)251015(17)270430(10)33F25J0698(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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,Followup
• Report Date (Section B): 02/13/2026

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: CDC-45703-XPCN1A
• Device Lot Number: 33F25J0698
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2025
• 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