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

Catalog Number	9079-VC-005
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: malfunction - during or after use.Additional information: propofol and fentanyl were infusing through io when it started leaking.User attempted to undo the extension set and reattach but continued to leak, then a 10cc syringe was attached to the io while they went to get a new extension set but leak continued through a crack in the io.The user felt it may be marrow leaking.The patient did have a central line which had medication running at the time and they attempted to insert a peripheral line but failed.Medication was swapped out of the central line for the sedation and the io was removed.Impact: the patient was not sedated when they should have been which caused discomfort.
Additional Manufacturer Narrative
Qn#(b)(4).The complaint cannot be confirmed.Complaint verification testing could not be performed as no sample was returned for analysis.A review of the certificate of compliance was performed with no relevant findings.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: malfunction - during or after use.Additional information: propofol and fentanyl were infusing through io when it started leaking.User attempted to undo the extension set and reattach but continued to leak, then a 10cc syringe was attached to the io while they went to get a new extension set but leak continued through a crack in the io.The user felt it may be marrow leaking.The patient did have a central line which had medication running at the time and they attempted to insert a peripheral line but failed.Medication was swapped out of the central line for the sedation and the io was removed.Impact: the patient was not sedated when they should have been which caused discomfort.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18847860
• Report Number: 3011137372-2024-00026
• Device Sequence Number: 7832261
• Product Code: FMI
• UDI-Device Identifier: 00816000011980
• UDI-Public: 00816000011980
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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 Catalogue Number: 9079-VC-005
• Device Lot Number: 69554796
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown