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	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "io access was attempted at the r proximal tibia site with a 25mm io needle by [clinician].The needle was unable to be removed.Multiple providers attempted multiple times to remove the needle unsuccessfully.It was opted to leave the io as is and move to the l humeral head with a 45mm io needle.Access was established successfully at this site with no complications".No patient harm or injury.The current status of the patient is "unknown" as this device was operated by the fire department which transferred the patient to the next phase of care in the hospital.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The complaint cannot be confirmed.Complaint verification testing could not be performed as no sample was returned for analysis.A review of the certificate of compliance was performed using a potential lot found through sale's history, and no relevant findings were identified.The ifu provided with this kit was reviewed as part of this complaint investigation.The ifu for this device states, "important: control patient movement prior to and during procedure.Squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force".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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "io access was attempted at the r proximal tibia site with a 25mm io needle by [clinician].The needle was unable to be removed.Multiple providers attempted multiple times to remove the needle unsuccessfully.It was opted to leave the io as is and move to the l humeral head with a 45mm io needle.Access was established successfully at this site with no complications".No patient harm or injury.The current status of the patient is "unknown" as this device was operated by the fire department which transferred the patient to the next phase of care in the hospital.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17930310
• Report Number: 3011137372-2023-00225
• Device Sequence Number: 6350791
• Product Code: FMI
• UDI-Device Identifier: 00816000011942
• UDI-Public: 00816000011942
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: UNKNOWN
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/05/2023
• 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