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-XPN1A
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "while inserting needle into patient for a central line it immediately returned air which is not common during this stage of the procedure.I was concerned i had caused a pneumothorax but the needle was not deep enough into the skin.I attempted from a different angle a second time and again got air in the syringe after penetrating the skin minimally.I again withdrew the needle and moved to a different location.When accessing the femoral vein with the same needle, while blood was filling up the syringe, i discovered blood coming from a crack in the plastic part of the needle where it connected to the syringe.I was still able to finish the procedure with no harm to the patient.No signs/symptoms of pneumothorax when i finished but a chest x-ray was performed to verify." the patient's current condition is reported as "critical".There was no patient harm or injury.The patient was in critical condition prior to using the product.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "while inserting needle into patient for a central line it immediately returned air which is not common during this stage of the procedure.I was concerned i had caused a pneumothorax but the needle was not deep enough into the skin.I attempted from a different angle a second time and again got air in the syringe after penetrating the skin minimally.I again withdrew the needle and moved to a different location.When accessing the femoral vein with the same needle, while blood was filling up the syringe, i discovered blood coming from a crack in the plastic part of the needle where it connected to the syringe.I was still able to finish the procedure with no harm to the patient.No signs/symptoms of pneumothorax when i finished but a chest x-ray was performed to verify." the patient's current condition is reported as "critical".There was no patient harm or injury.The patient was in critical condition prior to using the product.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 24413744
• Report Number: 9680794-2026-00122
• Device Sequence Number: 13393600
• Product Code: FOZ
• UDI-Device Identifier: 10801902162066
• UDI-Public: (01)10801902162066(11)251027(17)270131(10)33F25J0717(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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-42703-XPN1A
• Device Lot Number: 33F25J0717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2025
• 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