MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 25MM NEEDLE SET + STABILIZER; TUBING, PRESSURE AND ACCESSORI

Catalog Number	9001P-VC-005
Medical Device Problem Codes	Positioning Failure (1158); Patient-Device Incompatibility (2682); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Skin Tears (2516)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2023, an attempt was made to create an i.O.Access in the tibia with a 25 mm needle in a 19-year-old patient.After insertion during drilling, the needle started to rotate unevenly at the front and scraped the periosteum.The colleagues who were on site reported that there was soft tissue damage.On the second attempt, different side tibia, same problem.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for investigation.The customer returned the sharps container and the needle set from 9001p-vc-005 ez-io 25mm needle set + stabilizer.Visual inspection of the returned needle set revealed scratches on the proximal end of the cannula.The needle set was subjected to simulated saw bone insertions.This functional test is used to determine whether the returned needle set still has the capability to insert into a medium and/or hard bone.Two (2) saw bones with medium (50 lbs/ft3) and hard (105 lbs/ft3) hardness profiles with 3mm cortexes were used for the test.Each insertion was timed with a stopwatch while applying approximately 8 lbs.Of force on a weight scale.Approximately 5 to 8 lbs.Of force is necessary to penetrate bone.Below are the test results: medium profile (50 lbs/ft3)insertion 1: 2.00 secs, insertion 2: 1.97 secs, insertion 3: 2.10 secs, hard profile (105 lbs/ft3) insertion 1: 3.28 secs, insertion 2: 3.16 secs, insertion 3: 3.31 secs.The needle successfully negotiated both the medium and hard saw bone insertion testing.A review of the device certificate of compliance was performed with no findings available.The ez-io needle ifu states, "squeeze trigger and apply gentle, steady pressure.Important: do not use excessive force.Note: if ez-io power driver stalls and ez-io needle set will not penetrate the bone, operator may be applying too much downward pressure to penetrate bone." the device was released in 05/2023 and is approximately 7 months old.The reported complaint could not be confirmed.Functional testing revealed no fault found with this needle set as it was able to negotiate both the medium and hard saw bones during insertion testing.No defects or anomalies were observed with the returned needle set.A review of the certificate of compliance was performed and no recorded results of manufacturing issues or anomalies were reported.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2023, an attempt was made to create an i.O.Access in the tibia with a 25 mm needle in a 19-year-old patient.After insertion during drilling, the needle started to rotate unevenly at the front and scraped the periosteum.There was soft tissue damage.On the second attempt, different side tibia, same problem.Associated to 3011137372-2023-00250 and 3011137372-2023-00252.

• Brand Name: EZ IO 25MM NEEDLE SET + STABILIZER
• Common Device Name: TUBING, PRESSURE AND ACCESSORI
• 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: 18235870
• Report Number: 3011137372-2023-00251
• Device Sequence Number: 3227205
• Product Code: BYX
• UDI-Device Identifier: 00816000011881
• UDI-Public: 00816000011881
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9001P-VC-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 19 YR
• Patient Sex: Unknown