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); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during a central line placement, the clinician observed blood leaking from the hub of the introducer needle during aspiration.The procedure was stopped and was successfully completed using an alternate needle from the kit.It was later confirmed that there have been previous reports of cracked hubs on introducer needles with this kit." good faith efforts were made to obtain additional information regarding the reported device issues, including confirmation of the multiple reported occurrences and assessment of any patient harm.There were documented attempts made to contact the user facility; however, no response or additional information was received.Associated mdrs include (specific event) and 9680794-2026-00379 (multiple events without additional details).
Additional Manufacturer Narrative
Qn# (b)(4).

• 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: 25142111
• Report Number: 9680794-2026-00366
• Device Sequence Number: 13125099
• Product Code: FOZ
• UDI-Device Identifier: 10801902161243
• UDI-Public: (01)10801902161243(11)251001(17)270430(10)33F25J0683(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CDC-45703-XPCN1A
• Device Lot Number: 33F25J0683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2025
• 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.
• Patient Sex: Unknown