MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 25MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917322
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the operator attempted to establish a humeral io, which he stated he felt a pop, but then he was unable to unthread the stylet from the hollow needle.He thought he messed up the procedure then went straight to tibial w/a different needle.But, once again he was unable to unthread the stylet.Our ambulance provider arrived on scene, he used their ez-io system & was able to establish an io on the other tibia with no issues.There was no reported patient harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported that the operator "attempted to establish a humeral io, which he stated he felt a pop, but then he was unable to unthread the stylet from the hollow needle.He thought he messed up the procedure then went straight to tibial (w/a different needle).But, once again he was unable to unthread the stylet.Our ambulance provider arrived on scene, he used their ez-io system & was able to establish an io on the other tibia with no issues".There was no reported patient harm or injury.

• Brand Name: EZ IO 25MM 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16683016
• Report Number: 3011137372-2023-00085
• Device Sequence Number: 15251555
• Product Code: FMI
• UDI-Device Identifier: 10801902170344
• UDI-Public: 10801902170344
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 03/28/2023

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: IPN917322
• Device Catalogue Number: 9001P-VC-005
• Device Lot Number: 65112794
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/22/2023
• 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 Sex: Unknown