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

Model Number	IPN917347
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
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
Ems used 45mm in tibia and buried it.Wanted you to know because it seems like ems could benefit from training.Ccu did not know what service put needle in but said it was one of two.Also, ccu could benefit on removal education.I advised on what to do but they said they tried and could not remove.I told them to consult ortho for better tool to remove.Nurse i spoke to did not know if io ever worked all he knew is that the hub broke when they tried to remove.Patient condition is fine.Additional information: the broken part was removed by a physician using a clamp.
Event or Problem Description
Ems used 45mm in tibia and buried it (see photo attached).Wanted you to know because it seems like ems could benefit from training.Ccu did not know what service put needle in but said it was one of two.Also, ccu could benefit on removal education.I advised on what to do but they said they tried and could not remove.I told them to consult ortho for better tool to remove.Nurse i spoke to did not know if io ever worked all he knew is that the hub broke when they tried to remove.Patient condition is fine.Additional information: the broken part was removed by a physician using a clamp.
Additional Manufacturer Narrative
(b)(4).The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.The customer returned one photo for evaluation, please reference attached photo pic-tc# 20040904 sf046429.Visual inspection of the photo confirmed the needle hub was broken and had separated from its cannula.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 instructions for use (ifu) provided with this kit (8087a rev.04) instructs the user, "do not use excessive force.Use moderate steady downward pressure and allow needle set rotation to penetrate the bone.Stabilize needle set hub, disconnect 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 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 04/2021 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.No corrective/preventative actions will be assigned.The complaint of a broken needle hub was confirmed by visual inspection of the customer supplied photo.The photo revealed the needle hub had become separated from its cannula.The complaint sample was never returned to teleflex for investigation.Functional testing and investigation activities cannot be conducted.The ifu (8087a rev.04) instructs to not use excessive force.Use moderate steady downward pressure and allow needle set rotation to penetrate the bone.Stabilize needle set hub, disconnect driver, and remove stylet.The complaint root cause cannot be established.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: EZ-IO 45MM NEEDLE (BOX OF 5)
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12703947
• Report Number: 3011137372-2021-00293
• Device Sequence Number: 17277615
• Product Code: FMI
• UDI-Device Identifier: 10801902170634
• UDI-Public: 10801902170634
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/11/2021

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: 03/31/2025
• Device Model Number: IPN917347
• Device Catalogue Number: 9079-VC-005
• Device Lot Number: 7533514
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/29/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male