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	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The customer reported that while working on a pediatric code for an infant drowning, "[the user] attempted an insertion in the proximal tibia, insertion was successful.When attempting to thread out the stylet they found it to be stuck.[the user] attempted to remove with a significant amount of muscle with no success, two other partners attempted, no success.They even went as far as to use trauma scissor as a pliers and still could not get it to come apart.They have a short transport time and arrived at the hospital before a second insertion was attempted".The patient status was reported as "deceased".Additional information received from the customer stated that it was unknown how long from the patient suffering cardiac arrest to when io access was attempted, the patient was down for an unknown amount of time prior to emergency services' arrival.There was no vascular access attempted prior to the first io attempt.It was further reported, from the failed removal of the stylet to gaining vascular access at the hospital, the time delay was approximately 10 minutes.The time, date, and cause of death was not provided by the customer.
Event or Problem Description
The customer reported that while working on a pediatric code for an infant drowning, "[the user] attempted an insertion in the proximal tibia, insertion was successful.When attempting to thread out the stylet they found it to be stuck.[the user] attempted to remove with a significant amount of muscle with no success, two other partners attempted, no success.They even went as far as to use trauma scissor as a pliers and still could not get it to come apart.They have a short transport time and arrived at the hospital before a second insertion was attempted".The patient status was reported as "deceased".Additional information received from the customer stated that it was unknown how long it was from the patient suffering cardiac arrest to when io access was attempted, the patient was down for an unknown amount of time prior to emergency services' arrival.There was no vascular access attempted prior to the first io attempt.It was further reported, from the failed removal of the stylet to gaining vascular access at the hospital, the time delay was approximately 10 minutes.Aside from the report of a pediatric code for an infant drowning, the customer did not provide information about the time, date, and cause of death.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint could not be confirmed as no sample was returned for analysis.The ifu provided with this kit states, "important: control patient movement prior to and during procedure.Squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force." a review of the certificate of compliance was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause for the report of the stylet sticking 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.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17987159
• Report Number: 3011137372-2023-00226
• Device Sequence Number: 15495591
• Product Code: FMI
• UDI-Device Identifier: 00816000011942
• UDI-Public: 00816000011942
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown