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

Model Number	IPN917317
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/02/2021
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 medic was inserting 25mm io into patient and apparently it broke during insertion.
Event or Problem Description
Ems medic was inserting 25mm io into patient and apparently it broke during insertion.
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 cannula and stylet from an ez-io 25mm needle box.Visual inspection of the sample revealed that the distal end of the cannula was broken and had significant damage.Significant deformation was observed as the cannula appeared to be malformed and compressed in some fashion.Multiple scratches were also observed about halfway down the external cannula.R & d engineering was consulted for this complaint investigation.Based on the damage that was observed, it was determined that user error likely caused or contributed to this complaint issue.It is likely that the end user began the insertion at an offset or inappropriate angle and/or applied an excessive amount of force which could shear or distort the distal cannula.Therefore, the root cause is unintentional use error - clinician technique.The ez-io needle ifu (8087a rev.04) states, "squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force.Note: if ez-io power driver stalls and ez-io needle set will not penetrate the bone, operator may be applying too much downward pressure to penetrate bone.".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 02/2021 and is approximately 1 year old.The complaint has been confirmed.The device was returned with significant damage to the distal cannula.It has been determined that use error likely caused or contributed to this event.Therefore, no corrective actions are required at this time.The complaint of a broken needle cannula is confirmed.Visual inspection of the sample revealed that the distal end of the cannula was broken and had significant damage.Significant deformation was observed as the cannula appeared to be malformed and compressed in some fashion.Multiple scratches were also observed about halfway down the external cannula.A device history record review was performed and no relevant findings were identified.R & d engineering was consulted for this complaint investigation and based on the damage observed, it was determined that unintentional use error likely caused or contributed to this complaint issue.It is likely that the end user began the insertion at an offset or inappropriate angle and/or applied an excessive amount of force which could shear and distort the distal cannula.Therefore, the root cause is unintentional use error - clinician technique.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: EZ-IO 25MM 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: 13225236
• Report Number: 3011137372-2022-00004
• Device Sequence Number: 11787396
• Product Code: FMI
• UDI-Device Identifier: 10801902170337
• UDI-Public: 10801902170337
• Combination Product (Y/N): N
• 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): 12/15/2021

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: 01/31/2025
• Device Model Number: IPN917317
• Device Catalogue Number: 9001-VC-005
• Device Lot Number: 7256297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown