MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 45MM NEEDLE (BOX OF 5); NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9079-VC-005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "there was an incident a few months ago where someone pushed meds through a dislodged or incorrectly placed proximal humerus io that caused the patient to lose their arm".The current status of the patient is reported as "fine".Per the customer, "75% of their nurses are fresh out of nursing school and most don't know how to correctly place an io".Education classes were provided to the staff.
Event or Problem Description
It was reported that "there was an incident a few months ago where someone pushed meds through a dislodged or incorrectly placed proximal humerus io that caused the patient to lose their arm".The current status of the patient is reported as "fine".Per the customer, "75% of their nurses are fresh out of nursing school and most don't know how to correctly place an io".Education classes were provided to the staff.
Additional Manufacturer Narrative
Qn# (b)(4).Additional information received on 30 aug 2023 states that the io was placed in the left humeral head and "vasopressin, rocuronium, etomidate, vecuronium, txa, calcium chloride, versed, rocephin, ketamine and blood" was transfused through the io.Furthermore, "the patient never lost an arm.The patient had necrosis that developed that resulted in placement of a wound vac, hyperbaric treatments and eventually debridement of the area with a graft placed.From the supporting documentation, the patient was vomiting and to protect the patients airway the decision was made to intubate.Rsi medications were given through the io.The thought was the rsi medications contributed to the necrosis around the io site.Of note, documentation reports that ~ 5 minutes after the patient returned to ed from imaging, it was noted that blood was still infusing through the io and that the io was now beginning to infiltrate." complaint verification testing could not be performed as no sample was returned for analysis.A review of the certificate of compliance for this product was performed and no relevant findings were identified.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".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.Other remarks: n/a.Corrected data: section b4: date of this report corrected to 18-aug-2023.

• Brand Name: EZ-IO 45MM 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: 17590571
• Report Number: 3011137372-2023-00213
• Device Sequence Number: 2442711
• Product Code: FMI
• UDI-Device Identifier: 00816000011980
• UDI-Public: 00816000011980
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/18/2023

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: 9079-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: 06/21/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/15/2023
• 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
• Patient Sex: Male