MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 25MM NEEDLE (BOX OF 5); NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917317
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer reported that similar events occurred but the details of this were not provided.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
E80 responded to a cardiac arrest.They attempted to place a 25mm io needle and once they attempted to remove the inner cannula, it would not unscrew from the base.According to account this is now the 3rd time it has happened.Update:they did place a 15 mm io needle instead.
Additional Manufacturer Narrative
(b)(4).The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.Certificate of compliance (part of dhr), based on a potential lot # from sales history, 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 iso13485:2016.A review of the certificate of conformance/device history record found that the needle set passed all the release criteria.The device was released in 03/2021 and is approximately 0.5 years old.The complaint sample was never returned to teleflex for investigation.Functional testing and investigation activities cannot be conducted.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.Functional testing and investigation activities cannot be conducted.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
E80 responded to a cardiac arrest.They attempted to place a 25mm io needle and once they attempted to remove the inner cannula, it would not unscrew from the base.According to account this is now the 3rd time it has happened.Update:they did place a 15 mm io needle instead.

• Brand Name: EZ-IO 25MM NEEDLE (BOX OF 5)
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12341885
• Report Number: 3011137372-2021-00222
• Device Sequence Number: 3887319
• Product Code: FMI
• UDI-Device Identifier: 10801902170337
• UDI-Public: 10801902170337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/18/2021

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: IPN917317
• Device Catalogue Number: 9001-VC-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1