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

Catalog Number	9001-VC-005
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states "the emt-p stated she followed the proper landmarking and insertion of a 25mm needle in the proximal tibia and the needle separated from the hub at the point where the needle and hub meet.The hub stayed intact but came off of the needle.She then removed the needle and performed another insertion on the opposite tibia with a 45mm needle with the same issue.At this point a second emt-p stepped in and inserted another 25mm needle in the tibia without problem.A few minutes after our call i received an email and call from the quality & clinical manager stating she interviewed the 2nd emt-p and found the 1st emt-p was inserting on the lateral side of the tibia instead of the medial.The manager now believes this is a user issue and not a product issue".No report of patient harm or injury.The patient status is reported as "critical".See associated mdr #3011137372-2024-00031.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ez-io needle ifu 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." a review of the certificate of compliance was performed, and no relevant findings were identified.The certificate of compliance certifies the lot meets the quality system requirements and specifications.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The report states "the emt-p stated she followed the proper landmarking and insertion of a 25mm needle in the proximal tibia and the needle separated from the hub at the point where the needle and hub meet.The hub stayed intact but came off of the needle.She then removed the needle and performed another insertion on the opposite tibia with a 45mm needle with the same issue.At this point a second emt-p stepped in and inserted another 25mm needle in the tibia without problem.A few minutes after our call i received an email and call from the quality & clinical manager stating she interviewed the 2nd emt-p and found the 1st emt-p was inserting on the lateral side of the tibia instead of the medial.The manager now believes this is a user issue and not a product issue".No report of patient harm or injury.The patient status is reported as "critical".See associated mdr #3011137372-2024-00031.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18739186
• Report Number: 3011137372-2024-00032
• Device Sequence Number: 15047923
• Product Code: FMI
• UDI-Device Identifier: 00816000011942
• UDI-Public: 00816000011942
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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 Catalogue Number: 9001-VC-005
• Device Lot Number: 69554724
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/21/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown