MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917347
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
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
After io needle inserted, the patient was transferred back to ward and the head nurse found the needle was separated from the hub.The needle was removed by an orthopedics physician.
Event or Problem Description
After io needle inserted, the patient was transferred back to ward and the head nurse found the needle was separated from the hub.The needle was removed by an orthopedics physician.
Additional Manufacturer Narrative
Qn# (b)(4).The manufacturing dhr file 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 (formerly lake region medical) 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 and device history record found that the needle set passed all the release criteria.The device was manufactured in 01/2018 and is approximately 3.5 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.The complaint sample was never returned to teleflex for investigation purposes.The complaint root cause cannot be established.The complaint cannot be confirmed.

• Brand Name: EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11684648
• Report Number: 3011137372-2021-00094
• Device Sequence Number: 2899406
• Product Code: FMI
• UDI-Device Identifier: 10801902170634
• UDI-Public: 10801902170634
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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 Expiration Date: 12/31/2021
• Device Model Number: IPN917347
• Device Catalogue Number: 9079P-VC-005
• Device Lot Number: 5988828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1