MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 25MM NEEDLE (BOX OF 5; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917317
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
There was an issue with the needle not coming through.Additional information: the patient was in full cardiac arrest so i notified the doctor that i was going to insert an io in the left proximal tibia.I felt for my landmark.I inserted the io needle but was unable to detach the insertion device.There was another iv nurse at the bedside and she was unable to detach as well.I could not connect a syringe so i gave a pink needle to the other nurse and she inserted it in the right tibia.I removed the needle from the left tibia and saved it as i believe it was faulty.The nurse was able to give the meds through the other io needle.The patient expired, he was a cardiac arrest in the ed.No interventions were required another io was used without any incident.The clinical coordinator of emergency services/chief paramedic stated, from looking in this i do not believe that this incident with the i/o had any bearing on the patient's outcome another i/o was placed within minutes of identifying the issue with the first needle.
Event or Problem Description
There was an issue with the needle not coming through.The patient was in full cardiac arrest so i notified the doctor that i was going to insert an io in the left proximal tibia.I felt for my landmark.I inserted the io needle but was unable to detach the insertion device.There was another iv nurse at the bedside and she was unable to detach as well.I could not connect a syringe so i gave a pink needle to the other nurse and she inserted it in the right tibia.I removed the needle from the left tibia and saved it as i believe it was faulty.The nurse was able to give the meds through the other io needle.The patient expired, he was a cardiac arrest in the ed.No interventions were required another io was used without any incident.The clinical coordinator of emergency services/chief paramedic stated, from looking in this i do not believe that this incident with the i/o had any bearing on the patient's outcome another i/o was placed within minutes of identifying the issue with the first needle.
Additional Manufacturer Narrative
Qn#: (b)(4).The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.The customer returned one ez-io 25mm needle stylet for evaluation; the cannula was not returned.Visual inspection of the stylet did not reveal any defects or anomalies.The needle stylet had an outer diameter of 0.05090" (micrometer: ref-0002639), which is within the specifications of 0.0505"-0.0515" per stylet product drawing 1431 rev.01.Dimensional inspection of the needle cannula could not occur as it was not returned for investigation.A lab inventory 25 mm needle cannula was able to be attached to the returned needle stylet.The complete needle set was then subjected to simulated sawbone insertions using a lab inventory 9058 driver.This functional test is used to determine whether the returned device functions properly when drilled into a medium and/or hard bone.Two sawbones with medium (50 lbs/ft3) and hard (105 lbs/ft3) hardness profiles with 3mm cortexes were used for the test.Approximately 5 to 8 lbs.Of force is necessary to penetrate bone.The needle set was able to drill into the medium and hard sawbone with no issues.Additionally, the needle stylet was able to be unscrewed and removed from the needle cannula after drilling into both saw bones.Certificate of compliance (part of dhr) certifies that the aforementioned lot meets the viant quality system requirements and specifications.This product has been manufactured and controlled by viant in accordance with the fda qsr and iso 13485:2016.A review of the certificate of conformance/device history record found that the needle set passed all the release criteria.The device was released in 07/2020 and is under 1 year old.Corrective action is not required at this time as the probable cause could not be determined based upon the information provided and without the needle cannula returned for evaluation.No functional issues were found with the returned 25 mm needle stylet.Without the needle cannula 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 reports of this nature.

• Brand Name: EZ-IO 25MM NEEDLE (BOX OF 5
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11246087
• Report Number: 3011137372-2021-00004
• Device Sequence Number: 19721788
• Product Code: FMI
• UDI-Device Identifier: 10801902170337
• UDI-Public: 10801902170337
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K091140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 06/30/2024
• Device Model Number: IPN917317
• Device Catalogue Number: 9001-VC-005
• Device Lot Number: 6981191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1