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 Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by clinical staff that: "stylet could not be removed from catheter".The patients current condition is reported as "deceased".The patient was being treated for a reported "cardiac arrest".Additional information has been requested from the clinical staff.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A review of the certificate of compliance found that the needle set passed all the release criteria.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 complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported by clinical staff that: "stylet could not be removed from catheter".The patients current condition is reported as "deceased".The patient was being treated for a reported "cardiac arrest".Additional information has been requested from the clinical staff.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19310330
• Report Number: 3011137372-2024-00068
• Device Sequence Number: 3077178
• Product Code: FMI
• UDI-Device Identifier: 00816000011942
• UDI-Public: 00816000011942
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 9001-VC-005
• Device Lot Number: 6899488
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/04/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 57 YR
• Patient Sex: Female