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

Model Number	IPN917352
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
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
Medwatch (b)(4).Patient arrived as trauma activation on (b)(6) 2022 from the scene of a motorcycle crash.Patient was transported by lifenet medevac who placed intraosseous catheter in right humerus at 1540 pta in ed for access.An a-line and central line were placed in ed prior to or.No documentation of intraosseous catheter removal.On (b)(6) 2022 patient complained of pain in right shoulder with occupational therapy.X-rays ordered by ortho resident with note of retained foreign body, io needle.No documentation found of when io was removed.Typically, these are removed once central access obtained.Patient sent to or on (b)(6) 2022 to remove retained catheter needle, with no further complications.
Event or Problem Description
Medwatch (b)(4).Patient arrived as trauma activation on 10/2 from the scene of a motorcycle crash.Patient was transported by (b)(6) who placed intraosseous catheter in right humerus at 1540 pta in ed for access.An a-line and central line were placed in ed prior to operating room.No documentation of intraosseous catheter removal.On 10/12 patient complained of pain in right shoulder with occupational therapy.X-rays ordered by ortho resident with note of retained foreign body, io needle.No documentation found of when io was removed.Typically, these are removed once central access obtained.Patient sent to operating room on 10/15 to remove retained catheter needle, with no further complications.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device 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 for reports of this nature.

• Brand Name: EZ IO 45MM NEEDLE SET + STABILIZER
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15890626
• Report Number: 3011137372-2022-00215
• Device Sequence Number: 5209994
• Product Code: FMI
• UDI-Device Identifier: 10801902170641
• UDI-Public: 10801902170641
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• 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): 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: IPN917352
• Device Catalogue Number: 9079P-VC-005
• Device Lot Number: 55675249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male