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

Model Number	IPN917317
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
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
On the ezio 25mm 15ga needle set the paramedic reported that the hub would not come off the needle and the extension set has a crushed/melted end resulting in unable to use.The patient was in cardiac arrest.Io access was achieved with a second device.The device did not contribute to the patient's death.The problem was encountered when attempting to remove the hub/needle the device would not separate.The first device was left in the patient after the patient died.
Additional Manufacturer Narrative
(b)(4), the manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.Certificate of compliance (part of dhr) certifies that the aforementioned lot meets the viant upland quality system requirements and specifications.This product has been manufactured and controlled by viant upland in accordance with the fda qsr and iso iso13485:2016.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 03/2021 and is approximately 0.5 years old.The complaint sample was never returned to teleflex for investigation.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.The complaint cannot be confirmed.No corrective/preventative actions will be assigned.The complaint sample was never returned to teleflex for investigation.Functional testing and investigation activities cannot be conducted.The manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.The complaint root cause cannot be established.The complaint cannot be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
On the ezio 25mm 15ga needle set the paramedic reported that the hub would not come off the needle and the extension set has a crushed/melted end resulting in unable to use.The patient was in cardiac arrest.Io access was achieved with a second device.The device did not contribute to the patient's death.The problem was encountered when attempting to remove the hub/needle the device would not separate.The first device was left in the patient after the patient died.

• Brand Name: EZ-IO 15MM NEEDLE (BOX OF 5)
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12467746
• Report Number: 3011137372-2021-00250
• Device Sequence Number: 3780162
• Product Code: FMI
• UDI-Device Identifier: 10801902170337
• UDI-Public: 10801902170337
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101026
• 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): 09/10/2021

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 Model Number: IPN917317
• Device Catalogue Number: 9001-VC-005
• Device Lot Number: 7256299
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1