MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 15MM NEEDLE (BOX OF 5); NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9018-VC-005
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "they report inserting the 15mm needle into the proximal tibia as directed and being unable to unscrew the stylet from the cannula.After multiple provider attempts to unscrew the stylet, a second 15mm was used on the opposite leg with success.The needle set was recovered from the sharps safety bin and it was unknown how, but eventually the two pieces were unscrewed from each other.When speaking with the reporting party, i asked about the certainty of the needle set being connected to the catheter upon insertion and not just the stylet being placed into the patient's body.The reporting party could not answer if this was the possible occurrence.They reported having both pieces of the needle set.The device did not cause or contribute to the death.The on scene medic supervisor.Reporting party stated this was a sids case.Resuscitation would not have changed the outcome, even had the initial needle not failed." the patient's current condition is reported as "deceased".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "they report inserting the 15mm needle into the proximal tibia as directed and being unable to unscrew the stylet from the cannula.After multiple provider attempts to unscrew the stylet, a second 15mm was used on the opposite leg with success.The needle set was recovered from the sharps safety bin and it was unknown how, but eventually the two pieces were unscrewed from each other.When speaking with the reporting party, i asked about the certainty of the needle set being connected to the catheter upon insertion and not just the stylet being placed into the patient's body.The reporting party could not answer if this was the possible occurrence.They reported having both pieces of the needle set.The device did not cause or contribute to the death.The on scene medic supervisor.Reporting party stated this was a sids case.Resuscitation would not have changed the outcome, even had the initial needle not failed." the patient's current condition is reported as "deceased".
Additional Manufacturer Narrative
Qn# (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 not performed since the lot/batch number could not be provided.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.

• Brand Name: EZ-IO 15MM 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: 19103115
• Report Number: 3011137372-2024-00045
• Device Sequence Number: 7737437
• Product Code: FMI
• UDI-Device Identifier: 00816000011966
• UDI-Public: 00816000011966
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 9018-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: 03/20/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/14/2024
• Supplement Report FDA Received Date: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Age: 1 MO
• Patient Sex: Male