MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 25MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9001P-VC-005
Medical Device Problem Codes	Fitting Problem (2183); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the inner needle cannot be pulled out.Used on a patient and no patient harm.The product has been discarded and needs to be replaced with a new set." no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the inner needle cannot be pulled out.Used on a patient and no patient harm.The product has been discarded and needs to be replaced with a new set." no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with this kit states, "stabilize needle set hub, disconnect ez-io power driver, and remove stylet." the 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 iso13485:2016.A review of the potential certificate of compliances found that the needle set passed all the release criteria.The device was released in 02/2023 and is approximately 1.3 years old.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.

• Brand Name: EZ IO 25MM NEEDLE SET + STABILIZER
• 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: 19339920
• Report Number: 3011137372-2024-00074
• Device Sequence Number: 12548592
• Product Code: FMI
• UDI-Device Identifier: 00816000011881
• UDI-Public: 00816000011881
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/26/2024

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 Catalogue Number: 9001P-VC-005
• Device Lot Number: 68446311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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 Sex: Unknown