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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
Customer called stating that once the ez-io needle was inserted they were unable to remove the stylet.They removed the entire needle and used another needle to complete the procedure.Patient is fine.
Additional Manufacturer Narrative
(b)(4).For products manufactured by a third-party supplier, a review of the certificate of compliance is considered equivalent and can be performed in lieu of a dhr review.A review of the certificate of compliance was performed with no findings available.The customer returned one 9001-vc-001 ez-io 25 mm needle set for investigation.The needle set was returned opened and inside a safety needle vise.No original packaging or other components were returned.Visual inspection revealed that the needle set appeared typical.Dimensional inspection was not required as the device passed functional inspection and there were no defects or anomalies observed.Functional inspection was performed by attempting to manually screw apart the stylet hub from the cannula hub.The stylet was easily able to be unscrewed and removed from the cannula.The stylet was replaced into the cannula and multiple removal attempts were completed with the same results.There were no difficulties observed during the removal of the stylet from the cannula.The complaint cannot be confirmed.The ifu provided with this kit (8087a) was reviewed as part of this complaint investigation.The ifu states, "stabilize needle set hub, disconnect ez-io power driver, and remove stylet." the certificate of compliance (part of dhr) certifies that the aforementioned lot meets the viant upland quality system requirements and specifications.This product has been manufactured and controlled by viant upland in accordance with the fda qsr and iso iso13485:2003.A review of the certificate of compliance found that the needle set passed all the release criteria.The device was released in may 2020 and is approximately 2 years old.Corrective actions are not required at this time as the complaint cannot be confirmed.There were no defects or anomalies found with the returned needle set.The complaint of a tight needle stylet cannot be confirmed.The needle set was returned opened and inside a safety needle vise.Visual inspection revealed that the needle set appeared typical.Functional inspection was performed by attempting to manually screw apart the stylet hub from the cannula hub.The stylet was easily able to be unscrewed and removed from the cannula.The stylet was replaced into the cannula and multiple removal attempts were completed with the same results.There were no difficulties observed during the removal of the stylet from the cannula.No defects or anomalies were found with the returned device.A review of the certificate of compliance found that the needle set passed all the release criteria.Therefore, the complaint cannot be confirmed as there was no problem found with the needle set.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Customer called stating that once the ez-io needle was inserted they were unable to remove the stylet.They removed the entire needle and used another needle to complete the procedure.Patient is fine.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13956687
• Report Number: 3011137372-2022-00058
• Device Sequence Number: 4271527
• Product Code: FMI
• UDI-Device Identifier: 10801902170320
• UDI-Public: 10801902170320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K091140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 04/30/2024
• Device Model Number: IPN917316
• Device Catalogue Number: 9001-VC-001
• Device Lot Number: 6948640
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/18/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown