MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 15MM NEEDLE (BOX OF 5); NEEDLE, HYPODERMIC, SINGLE LU

Catalog Number	9018-VC-005
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "[the user] had two 15mm ez-io needles function inappropriately on scene of a call.The patient was a 2yo in cardiac arrest prior to the arrival of ems, and was not able to be revived after resuscitative efforts.The paramedic on scene reported to him that the initial attempt for intraosseous access resulted in the inability to unscrew the stylet from the hub.In a second attempt, a different 15mm ez-io needle was removed from packaging with the paramedic stating that, prior to attempt, he tested the ability of the stylet to screw and unscrew from the hub.The paramedic then stated that the once the needle was placed into the patient, the stylet on that needle would not unscrew from the hub, by hand or with pliers.An amr unit then arrived on scene and was able to successfully place an ez-io needle from their supply.He assured me that the paramedic on scene was very experienced in ez-io, and would not have bent the needle or removed the stylet prior to attempt".Additional information received from the customer states that the patient had been sick for 2 days with fever and a cough.Upon ems's arrival on scene, the patient was in asystole with no pulse, the father was performing cpr.The customer states that "no, the io failure did not contribute to the death".Please see associated mdr #3011137372-2023-00242.
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
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 was performed using two potential lot numbers found through sale's history, and no relevant findings were identified.The ifu provided with this kit was reviewed as part of this complaint investigation.The ifu for this device 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.
Event or Problem Description
It was reported by the customer that "[the user] had two 15mm ez-io needles function inappropriately on scene of a call.The patient was a 2yo in cardiac arrest prior to the arrival of ems, and was not able to be revived after resuscitative efforts.The paramedic on scene reported to him that the initial attempt for intraosseous access resulted in the inability to unscrew the stylet from the hub.In a second attempt, a different 15mm ez-io needle was removed from packaging with the paramedic stating that, prior to attempt, he tested the ability of the stylet to screw and unscrew from the hub.The paramedic then stated that the once the needle was placed into the patient, the stylet on that needle would not unscrew from the hub, by hand or with pliers.An amr unit then arrived on scene and was able to successfully place an ez-io needle from their supply.He assured me that the paramedic on scene was very experienced in ez-io, and would not have bent the needle or removed the stylet prior to attempt".Additional information received from the customer states that the patient had been sick for 2 days with fever and a cough.Upon ems's arrival on scene, the patient was in asystole with no pulse, the father was performing cpr.The customer states that "no, the io failure did not contribute to the death".Please see associated mdr #3011137372-2023-00242.

• Brand Name: EZ-IO 15MM 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18149334
• Report Number: 3011137372-2023-00243
• Device Sequence Number: 12180497
• Product Code: FMI
• UDI-Device Identifier: 00816000011966
• UDI-Public: 00816000011966
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/27/2023

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: 9018-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: 10/27/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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 Age: 2 YR
• Patient Sex: Unknown