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 Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Io that was used during a cardiac arrest.Both messages refer to the same io.After inserting the io we were unable to remove the inner cannula.It would not separate from the body of the io.I have periodically encountered this in the past.Unsure of the malfunction.When i inserted the io, it would not twist off.It was as if the plastic was fussed together.We kept trying to twist but it would just twist out of pts leg.One of the members said it happened to them before.It was a manufactures defect i suppose because that had never happened to me before.
Additional Manufacturer Narrative
Qn# (b)(4).The manufacturing dhr file based on a potential lot was reviewed.No recorded results of manufacturing issues or anomalies were reported.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 iso13485:2016.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 11/2020 and is less than a year old.The complaint sample is not available for return.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 is not available for return.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.The complaint cannot be confirmed.No further action required.
Event or Problem Description
Io that was used during a cardiac arrest.Both messages refer to the same io.After inserting the io we were unable to remove the inner cannula.It would not separate from the body of the io.I have periodically encountered this in the past.Unsure of the malfunction.When i inserted the io, it would not twist off.It was as if the plastic was fussed together.We kept trying to twist but it would just twist out of pts leg.One of the members said it happened to them before.It was a manufactures defect i suppose because that had never happened to me before.

• 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: 11706507
• Report Number: 3011137372-2021-00129
• Device Sequence Number: 14237487
• Product Code: FMI
• UDI-Device Identifier: 10801902170337
• UDI-Public: 10801902170337
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/20/2021

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?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1