MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 45MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917352
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the paramedic attempted to establish a humeral io.The paramedic felt a pop, but was unable to unthread the stylet from the hollow needle.He then attempted to establish a tibial io with a different needle, but again was unable to unthread the stylet.The ambulance provider arrived on scene and used their ez-io system, which was able to establish an io on the other tibia with no issues.No patient harm or injuries.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the paramedic attempted to establish a humeral io.The paramedic felt a pop, but was unable to unthread the stylet from the hollow needle.He then attempted to establish a tibial io with a different needle, but again was unable to unthread the stylet.The ambulance provider arrived on scene and used their ez-io system, which was able to establish an io on the other tibia with no issues.No patient harm or injuries.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of having issues removing the stylet from the needle could not be confirmed based on the sample received.The customer returned various components, including a 45mm needle that appear to be from 9079p-vc-005 needle set.The returned needle was visually examined with and without magnification.Visual inspection of the returned needle revealed the needle appears used , as foreign material can be seen on the cannula.No other defects or anomalies were observed.Dimensional inspection was not required as a part of this complaint investigation.Functional testing of the returned needle revealed the needle's stylet could be removed and inserted into the returned needle's cannula with little effort.A review of the certificate of compliance certified that the received lot number met the viant upland quality system requirements and specifications and revealed that the needle set passed all the release criteria.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: EZ IO 45MM 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16912246
• Report Number: 3011137372-2023-00138
• Device Sequence Number: 16739573
• Product Code: FMI
• UDI-Device Identifier: 10801902170641
• UDI-Public: 10801902170641
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/20/2023

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 Expiration Date: 07/31/2026
• Device Model Number: IPN917352
• Device Catalogue Number: 9079P-VC-005
• Device Lot Number: 65112794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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