MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 25MM NEEDLE (EA); NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917316
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after insertion on a critically ill multi-system trauma patient, the user was unable to remove the stylet.As a result, a new ez-io was inserted successfully and used without issue.The patient ultimately expired "in or 1-2 hours after hand-off in ed".Additional information states that the cause of death was "exsanguination".It is also reported that "the ez-io failure does not appear to be the direct cause of this patient's death".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A review of the certificate of compliance was performed and revealed that found that the needle set passed all the release criteria and no other issues were identified.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that after insertion on a critically ill multi-system trauma patient, the user was unable to remove the stylet.As a result, a new ez-io was inserted successfully and used without issue.The patient ultimately expired "in or 1-2 hours after hand-off in ed".Additional information states that the cause of death was "exsanguination".It is also reported that "the ez-io failure does not appear to be the direct cause of this patient's death".

• Brand Name: EZ-IO 25MM NEEDLE (EA)
• 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 27560
• MDR Report Key: 17335123
• Report Number: 3011137372-2023-00189
• Device Sequence Number: 6477613
• Product Code: FMI
• UDI-Device Identifier: 10801902170320
• UDI-Public: 10801902170320
• Combination Product (Y/N): N
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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 Model Number: IPN917316
• Device Catalogue Number: 9001-VC-001
• Device Lot Number: 66209202
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 32 YR
• Patient Sex: Female
• Patient Weight: 84 KG