MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917352
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
I attempted to remove io needle after tlc placement confirmed.Unable to remove device difficult to turn device with syringe.Patient complained of severe pain when i tried to remove device.I tried turning device with syringe and attempted remove with hemostats.I notified team of difficulty asked for premedication.Action: medicated with fentanyl and rn attempted to remove device.Yellow plastic cap broke, leaving io needle in patient's arm.X/r of arm taken.
Event or Problem Description
I attempted to remove io needle after tlc placement confirmed.Unable to remove device difficult to turn device with syringe.Patient complained of severe pain when i tried to remove device.I tried turning device with syringe and attempted remove with hemostats.I notified team of difficulty asked for premedication.Action: medicated with fentanyl and rn attempted to remove device.Yellow plastic cap broke, leaving io needle in patient's arm.X/r of arm taken.
Additional Manufacturer Narrative
Qn# (b)(4).The manufacturing dhr file was not able to be reviewed as no lot number was provided and sales history for this customer was unavailable.The complaint sample is not available for return.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 is not available for return.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.The complaint cannot be confirmed.No further action required.

• Brand Name: EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11605423
• Report Number: 3011137372-2021-00079
• Device Sequence Number: 11850247
• Product Code: FMI
• UDI-Device Identifier: 10801902170641
• UDI-Public: 10801902170641
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/17/2021

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: IPN917352
• Device Catalogue Number: 9079P-VC-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1