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

Catalog Number	9079P-VC-005
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "io kit came defective which wasn't discovered until the needle was already placed into pt's bone.Once needle was drilled in and was presumed to be in correct placement, it was noted that the needle set did not come apart so that it could be attached to extension tubing, rending the iv site unusable.Needle was removed and iv access was eventually able to be obtained." no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A review of the certificate of compliance found that the needle set passed all the release criteria.The ifu provided with this kit states , "important: control patient movement prior to and during procedure.Squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force".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.
Event or Problem Description
It was reported "io kit came defective which wasn't discovered until the needle was already placed into pt's bone.Once needle was drilled in and was presumed to be in correct placement, it was noted that the needle set did not come apart so that it could be attached to extension tubing, rending the iv site unusable.Needle was removed and iv access was eventually able to be obtained." no medical intervention required.The patient's current condition is reported as "fine".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19339823
• Report Number: 3011137372-2024-00073
• Device Sequence Number: 12545396
• Product Code: FMI
• UDI-Device Identifier: 00816000011904
• UDI-Public: 00816000011904
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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
• Device Catalogue Number: 9079P-VC-005
• Device Lot Number: 69548929
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown