MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO POWER DRIVER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number IPN915667

Device Problem Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: loss of power during attempt to drill the needle into the bone.This occurred during reanimation.The led was green.

Event Description

Reported issue: loss of power during attempt to drill the needle into the bone.This occurred during reanimation.The led was green.

Manufacturer Narrative

Qn# (b)(4).The device was not returned for investigation.A copy of the manufacturing device history file was reviewed, and no recorded results of manufacturing issues or anomalies were reported.Two ifus will be referenced for this investigation.The ez-io driver ifu (8048a) 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 (8087a) states, "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.The device was released in (b)(6) 2018 and is approximately 5 years old.Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without a sample.Complaint verification testin g could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Reported issue: loss of power during attempt to drill the needle into the bone.This occurred during reanimation.The led was green.

Manufacturer Narrative

(b)(4).Ez-io driver 9058 was returned for evaluation.Upon receipt, the driver was visually inspected.When the trigger was pulled, the driver was operable, and a solid green led light was displaying.The driver was then subjected to simulated sawbone insertions per driver ifu.This functional test is used to determine whether the returned device still has the capability to power a 45mm ez-io needle set into a medium and/or hard bone.The 45mm ez-io needle set is used because it represents the worst-case scenario for io insertion.Two sawbones with medium and hard hardness profiles with 3mm cortexes were used for the test.Each insertion was timed with a stopwatch while applying approximately 8 lbs.Of force on a weight scale.Approximately 5 to 8 lbs.Of force is necessary to penetrate bone.The driver successfully negotiated both the medium and hard saw bone insertion testing.The complaint cannot be confirmed.The driver was opened to test and record operating characteristics.The eeprom results confirm that the battery is not depleted as the charge count has not exceeded the maximum depletion value of 15,300,000 per ver0190 accel biotech firmware verification test report.Additionally, 2 stall conditions were recorded.The ez-io needle ifu states, "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." testing confirms that there was no fault found with the returned driver.A copy of the manufacturing device history file was reviewed.No recorded results of manufacturing issues or anomalies were reported.A review of the device history record found that the driver passed all the release criteria.The device was released in 01/2018 and is approximately 5 years old.The complaint cannot be confirmed.Functional testing revealed no fault found with this driver as the device was able to negotiate both the medium and hard saw bones during insertion testing.No defects or anomalies were observed with the returned driver.Bone." a device history record review was performed, and no recorded results of manufacturing issues or anomalies were reported.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: EZ-IO POWER DRIVER
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16039790
• MDR Text Key: 308235671
• Report Number: 3011137372-2022-00253
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

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
• Device Operator: Health Professional
• Device Model Number: IPN915667
• Device Catalogue Number: 9058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/10/2023; 02/10/2023
• Supplement Dates FDA Received: 02/17/2023; 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED; NONE REPORTED