MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO INTRAOSSEOUS INFUSION SYSTEM - DRIVERS; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN915667
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Ez-io power driver failed to operate.The light would initially illuminate green for less than a second and then the device would die out.The device no longer has any light turn on and does not work.There was never a red light that illuminated on the device.Another driver was obtained.There was no patient injury or consequence.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Two ifus were referenced for this investigation.The ez-io driver ifu states, "as with any emergency medical device carrying a backup is strongly advised protocol", "ez-io power driver led will blink red when the trigger is activated and has only 10% of battery life remaining", and "purchase and replace the ez-io power driver when the red led begins blinking"."when storing the vascular access pak (vap), remove the trigger guard to prevent accidental activation of the ez-io power driver".The ez-io needle ifu "squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force.Note: if ez-io power driver stalls and ez-io needle set will not penetrate the bone, operator may be applying too much downward pressure to penetrate bone.".A review of the device history record found that the driver passed all the release criteria.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Manufacturer will continue to monitor and trend for reports of this nature.
Event or Problem Description
Ez-io power driver failed to operate.The light would initially illuminate green for less than a second and then the device would die out.The device no longer has any light turn on and does not work.There was never a red light that illuminated on the device.Another driver was obtained.There was no patient injury or consequence.

• Brand Name: EZ-IO INTRAOSSEOUS INFUSION SYSTEM - DRIVERS
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15470725
• Report Number: 3011137372-2022-00186
• Device Sequence Number: 11842961
• Product Code: FMI
• UDI-Device Identifier: 10816000013813
• UDI-Public: 10816000013813
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Model Number: IPN915667
• Device Catalogue Number: 9058
• Device Lot Number: K55075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown