MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ-IO 25MM NEEDLE SET-EU CONFIGURATION; TUBING, PRESSURE AND ACCESSORI

Catalog Number 9001-EU-001

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint sample is not available for return.Functional testing and investigation activities cannot be conducted.The complaint root cause cannot be established.The complaint cannot be confirmed.The device history review file is not available for review in the us.The ifu states, "attach luer-lock syringe to hub of catheter.Withdraw the catheter by applying traction while rotating the syringe and catheter clockwise.Maintain axial alignment during removal.Do not rock or bend the catheter." a review of the certificate of compliance could not be accomplished as the product lot number was not reported.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a patient has had an io needle removed from the shin/tibia but the needle snapped and the needle fragments were retained in the shin/tibia.The patient will require an operation to remove the needle fragments when he is more stable.

• Brand Name: EZ-IO 25MM NEEDLE SET-EU CONFIGURATION
• Type of Device: TUBING, PRESSURE AND ACCESSORI
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 8315761
• MDR Text Key: 135382420
• Report Number: 3011137372-2019-00049
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9001-EU-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention