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

Catalog Number 9079-VC-005

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Discomfort (2330)

Event Date 01/21/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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)
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LU
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18847860
• MDR Text Key: 337326493
• Report Number: 3011137372-2024-00026
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00816000011980
• UDI-Public: 00816000011980
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K180395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9079-VC-005
• Device Lot Number: 69554796
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.