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

Model Number	IPN917347
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Customer contacted cs on march 17th stating that they had attempted to use a needle on a patient that was in cardiac arrest.They noticed that the needle had been bonded together so they were unable to use it.I reached out to the customer on march 18th but did not receive a response until april 7th.
Additional Manufacturer Narrative
Qn# (b)(4).The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.The ifu states the following: advance ez-io needle set and release trigger.Pediatrics: release trigger when sudden "give" or "pop" is felt, indicating entry into medullary space.Adults: advance ez-io needle set approximately 1 cm after entry into medullary space; in proximal humerus for most adults catheter should be advanced until needle hub is flush or against the skin (this may be more than approximately 1 cm).7.Stabilize needle set hub, disconnect ez-io power driver, and remove stylet.The attached 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 iso13485:2016.A review of the certificate of conformance/device history record found that the needle set passed all the release criteria.The device was manufactured in 12/2019 and is approximately 1.5 years old.The complaint sample was never returned to teleflex for investigation purposes.The complaint root cause cannot be established.The complaint cannot be confirmed.No corrective/preventative actions will be assigned.The complaint sample was never returned to teleflex for investigation purposes.The complaint root cause cannot be established.The complaint cannot be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Customer contacted cs on march 17th stating that they had attempted to use a needle on a patient that was in cardiac arrest.They noticed that the needle had been bonded together so they were unable to use it.I reached out to the customer on march 18th but did not receive a response until april 7th.

• Brand Name: EZ-IO 45MM NEEDLE (BOX OF 5)
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11699955
• Report Number: 3011137372-2021-00114
• Device Sequence Number: 3436308
• Product Code: FMI
• UDI-Device Identifier: 10801902170634
• UDI-Public: 10801902170634
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/07/2021

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: IPN917347
• Device Catalogue Number: 9079-VC-005
• Device Lot Number: 6654085
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1