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); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we had 2 with cracked hubs pulling in air".There was no patient harm or injury.No medical intervention required.The patient's current condition is unknown at this time.Associate mdr numbers include: 9680794-2026-00167.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we had 2 with cracked hubs pulling in air".There was no patient harm or injury.No medical intervention required.The patient's current condition is unknown at this time.Associate mdr numbers include:9680794-2026-00168 and 9680794-2026-00167.
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided one photo for evaluation.The complaint of a cracked needle hub was confirmed by the photo, which shows a distinct crack in the needle hub of the 18ga introducer needle.No definite signs of use were observed.The customer also returned an unopened cvc kit for analysis.Visual analysis revealed that the needle hub contained a crack on the hub.Microscopic examination confirmed the cracks.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, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol , acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin".The customer report of needle hub cracked was confirmed by evaluation of the returned sample.Visual analysis revealed a crack in the needle hub.The failure mode identified is consistent with the failure mode investigated per a previously opened capa.Based on the capa investigation, the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.The capa was implemented using a new alcohol-resistant material to manufacture the needle hub.The needle hub from this complaint was confirmed to be made from the old needle hub material.Teleflex will continue to monitor and trend for reports of this nature.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24559337
• Report Number: 9680794-2026-00168
• Device Sequence Number: 10114669
• Product Code: FOZ
• UDI-Device Identifier: 10801902161243
• UDI-Public: (01)10801902161243(11)251015(17)270430(10)33F25J0694(21)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/11/2026

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: 33F25J0694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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