MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 15MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917337
Medical Device Problem Codes	Difficult to Flush (1251); Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during resuscitation efforts on a patient that arrived to the facility in full cardiopulmonary arrest, the user was unable to prime and flush the extension set of the io.As a result, a 2nd extension set was opened but was also unable to be primed and flushed.Ultimately, an io was placed successfully with the use of a competitor device.Despite best efforts, the patient expired.Additional information states that the physician does not assert that the inability to flush the extension set contributed to the patient's death.
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 it was found out that the lot met the quality system requirements and specifications.This product has been manufactured and controlled in accordance with the fda qsr and iso.The needle set passed all the release criteria.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.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 during resuscitation efforts on a patient that arrived to the facility in full cardiopulmonary arrest, the user was unable to prime and flush the extension set of the io.As a result, a 2nd extension set was opened but was also unable to be primed and flushed.Ultimately, an io was placed successfully with the use of a competitor device.Despite best efforts, the patient expired.Additional information states that the physician does not assert that the inability to flush the extension set contributed to the patient's death.

• Brand Name: EZ IO 15MM 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16953313
• Report Number: 3011137372-2023-00135
• Device Sequence Number: 6915958
• Product Code: FMI
• UDI-Device Identifier: 10801902170498
• UDI-Public: 10801902170498
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: IPN917337
• Device Catalogue Number: 9018P-VC-005
• Device Lot Number: 7611681
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/20/2023
• 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: 11 DA
• Patient Sex: Male