MAUDE Adverse Event Report: TELEFLEX ARROW EZ-IO NEEDLE AND STABILIZER KIT

Model Number	9001P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Arrow ez-io 25mm 15 ga needle was inserted into patient's tibia.After placement, it was noted that there was not a catheter, only a needle.

• Brand Name: ARROW EZ-IO NEEDLE AND STABILIZER KIT
• Common Device Name: ARROW EZ-IO NEEDLE AND STABILIZER KIT
• Manufacturer (Section D): TELEFLEX; morrisville NC 27560
• MDR Report Key: 7272647
• Report Number: MW5075239
• Device Sequence Number: 2300742
• Product Code: FMI
• UDI-Device Identifier: 10816000011888
• UDI-Public: (01)10816000011888
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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 Expiration Date: 07/31/2021
• Device Model Number: 9001P
• Device Lot Number: 5576429
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Weight: 82