MAUDE Adverse Event Report: Teleflex Medical ARROW EZ IO 45MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9079P-VC-005
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: ARROW EZ IO 45MM NEEDLE SET + STABILIZER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): Teleflex Medical; athlone
• Manufacturer (Section G): Teleflex Medical; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50844821
• Report Number: 3011137372-2026-00281
• Device Sequence Number: 15967524
• Product Code: FMI
• UDI-Device Identifier: 10816000013981
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 9079P-VC-005
• Device Lot Number: 87569549
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2025
• 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
• Patient Sex: Unknown