MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO INTRAOSSEOUS INFUSION SYSTEM - NEEDLE SE; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917352
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
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
Rn went to remove io from left humerus.When twisting off the extension tubing, luerlock, from the plastic head portion of the needle, the plastic portion came off.The needle appears to remain embedded within the patient's left humerus.In reviewing the psls, the needle was resected out at the bedside without complication.I think i remember the nurse telling me that they used a needle driver to pull it out.The event occurred back in october and the patient's current condition is unknown.They have since been discharged from the hospital.The needle was removed at the bedside by a physician.As per the icu progress note on october 27 the broken needle of his io needle was resected out.It does not elaborate in what manner this was done.
Additional Manufacturer Narrative
(b)(4).The manufacturing dhr file based on a potential lot 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 01/2021 and is less than a year old.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.
Event or Problem Description
Rn went to remove io from left humerus.When twisting off the extension tubing, luerlock, from the plastic head portion of the needle, the plastic portion came off.The needle appears to remain embedded within the patient's left humerus.In reviewing the psls, the needle was resected out at the bedside without complication.I think i remember the nurse telling me that they used a needle driver to pull it out.The event occurred back in october and the patient's current condition is unknown.They have since been discharged from the hospital.The needle was removed at the bedside by a physician.As per the icu progress note on october 27 the broken needle of his io needle was resected out.It does not elaborate in what manner this was done.

• Brand Name: EZ-IO INTRAOSSEOUS INFUSION SYSTEM - NEEDLE SE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12019202
• Report Number: 3011137372-2021-00158
• Device Sequence Number: 3304903
• Product Code: FMI
• UDI-Device Identifier: 10801902170641
• UDI-Public: 10801902170641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/02/2021

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: 06/02/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention