MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 45MM NEEDLE (BOX OF 5); NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917347
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
Event or Problem Description
Medwatch# (b)(4).The patient experienced a cardiac arrest and the patient did not have vascular access.The team assessed the situation and decided the patient would benefit from an intraosseous needle.The critical care nurse used the ez-io power driver and placed an ez-io 45 mm needle in the patient's proximal tibia.The rn followed the manufacturer's instructions for placement.Approximately 5 hours later, the patient's status changed and the io was no longer needed.The critical care nurse began the removal procedure per the manufacturer's instructions for removal.After the needle was removed, the rn noticed the needle was not intact and over one inch of the needle remained in the patient's tibia.The needle had broken approximately 0.125 inches below the yellow hub.The broken needle part was removed.The patient expired as a result of cardiac arrest and comorbidities.
Event or Problem Description
Medwatch# (b)(4).The patient experienced a cardiac arrest and the patient did not have vascular access.The team assessed the situation and decided the patient would benefit from an intraosseous needle.The critical care nurse used the ez-io power driver and placed an ez-io 45 mm needle in the patient's proximal tibia.The rn followed the manufacturer's instructions for placement.Approximately 5 hours later, the patient's status changed and the io was no longer needed.The critical care nurse began the removal procedure per the manufacturer's instructions for removal.After the needle was removed, the rn noticed the needle was not intact and over one inch of the needle remained in the patient's tibia.The needle had broken approximately 0.125 inches below the yellow hub.The broken needle part was removed.The patient expired as a result of cardiac arrest and comorbidities.
Additional Manufacturer Narrative
(b)(4).The manufacturing dhr file could not be reviewed as no lot number was provided and no sales history was found for the customer.The customer returned one ez-io 45 mm needle set for evaluation.The customer only returned the needle cannula, with no stylet or any of the needle set packaging.Upon receipt, the sample was visually inspected.Visual inspection revealed that the cannula was broken at the proximal end of the cannula near the base of the yellow hub.The complaint is confirmed.Further inspection under microscopic imaging revealed visual evidence of stripped threading on the yellow hub.There were also multiple scratches found on the distal end of the hub.The stripped threading is an indication of excessive force being applied on the hub during removal.The scratches are likely the result of some type of removal tool that grasped the sides of the hub with a significant amount of force.Therefore, the most likely cause of this event is unintentional user error - excessive force.The ez-io needle ifu (8087a rev.04) states, "to remove ez-io from patient: attach luer-lock syringe to hub of catheter.Maintain axial alignment and rotate clockwise while pulling straight out.Do not rock or bend the catheter.Improper technique may cause catheter to break." corrective action is not required at this time as the observed damage indicates that user error likely caused or contributed to this event.No further action will be taken.The complaint is confirmed.Visual inspection revealed that the cannula was broken at the proximal end of the cannula near the base of the yellow hub.Further inspection under microscopic imaging revealed visual evidence of stripped threading on the yellow hub.There were also multiple scratches found on the distal end of the hub.The stripped threading is an indication of excessive force being applied on the hub during removal.The scratches are likely the result of some type of removal tool that grasped the sides of the hub with a significant amount of force.Therefore, the most likely cause of this event is unintentional user error - excessive force.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: EZ-IO 45MM NEEDLE (BOX OF 5)
• 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: 14842934
• Report Number: 3011137372-2022-00122
• Device Sequence Number: 11960509
• Product Code: FMI
• UDI-Device Identifier: 10801902170634
• UDI-Public: 10801902170634
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: IPN917347
• Device Catalogue Number: 9079-VC-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown