MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 45MM NEEDLE (BOX OF 5); NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9079-VC-005
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the md at the emergency center inserted the ez-io needle into the right upper humerus of the patient in cardiopulmonary arrest, in order to inject more volume of the medical agent.However, the condition of the patient did not improve and finally died.When a trainee doctor was removing the needle, the cannula broke, the issue occurred after the patient died.The customer stated that there was no causal relationship between the device and the patient's death.".
Additional Manufacturer Narrative
(b)(4).The reported complaint was confirmed based on the investigation of the returned sample.The customer provided one photo and returned one unit 9079-vc-005 ez-io 45mm needle (box of 5) for evaluation.Visual inspection revealed that the 45mm ez-io cannula was broken and separated.A review of the certificate of compliance was performed with no findings available.Additionally, the ifu states "to remove ez-io from patient: a.Remove ez-connect extension set.B.Lift & remove ez-stabilizer dressing.C.Attach luer-lock syringe to hub of cannula.Maintain axial alignment and rotate clockwise while pulling straight out.Do not rock or bend the cannula.Improper technique may cause cannula to break".It was determined that there was sufficient evidence to confirm that this damage was the result of undue force.For the stainless-steel cannula to experience this failure mode, there likely was excessive force applied at an off angle during removal.Based upon the damage observed, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "the md at the emergency center inserted the ez-io needle into the right upper humerus of the patient in cardiopulmonary arrest, in order to inject more volume of the medical agent.However, the condition of the patient did not improve and finally died.When a trainee doctor was removing the needle, the cannula broke, the issue occurred after the patient died.The customer stated that there was no causal relationship between the device and the patient's death.".

• Brand Name: EZ-IO 45MM NEEDLE (BOX OF 5)
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23942657
• Report Number: 3011137372-2026-00001
• Device Sequence Number: 10684047
• Product Code: FMI
• UDI-Device Identifier: 00816000011980
• UDI-Public: (01)00816000011980(11)240814(17)280731(10)74697373(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 9079-VC-005
• Device Lot Number: 74697373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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