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

Catalog Number	9001P-VC-005
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "an io was used on a patient in our emergency department.It was left in for 24hrs and removed.When the nurses attempted to remove it, they could not get it out.Multiple people tried and finally an er nurse came up to the floor to remove it.When it finally loosened to come out, the needle was broken off and stayed inside the patient".Additional information reports, "the patient has not been meaningfully responsive since arrival to the hospital.This patient has been recommended to hospice care for reasons unrelated to this event".The patient received an xray but the product was not removed from the patient.No patient harm or injury reported.No medical intervention required.
Event or Problem Description
It was reported "an io was used on a patient in our emergency department.It was left in for 24hrs and removed.When the nurses atte mpted to remove it, they could not get it out.Multiple people tried and finally an er nurse came up to the floor to remove it.When it finally loosened to come out, the needle was broken off and stayed inside the patient".Additional information reports, "the patient has not been meaningfully responsive since arrival to the hospital.This patient has been reccomended to hospice care for reasons unrelated to this event".The patient received an xray but the product was not removed from the patient.No patient harm or injury reported.No medical intervention required.
Additional Manufacturer Narrative
(b)(4).The complaint cannot be confirmed.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 "attach luer-lock syringe to hub of cannula.Maintain axial alignment and rotate clockwise while pulling straight out.Do not rock or bend the cannula.Improper technique may cause cannula to break".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.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19200584
• Report Number: 3011137372-2024-00053
• Device Sequence Number: 20815155
• Product Code: FMI
• UDI-Device Identifier: 00816000011881
• UDI-Public: 00816000011881
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 9001P-VC-005
• Device Lot Number: 63802333
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/28/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown