MAUDE Adverse Event Report: TELEFLEX MEDICAL EZ IO 25MM NEEDLE SET + STABILIZER; NEEDLE, HYPODERMIC, SINGLE LU

Model Number	IPN917322
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4); n/a; other remarks: n/a; corrected data: n/a.
Event or Problem Description
It was reported that when attempting to remove "an io device, the hub broke free from the needle leaving the needle in the patient's tibia".Additional information states that the bedside nurse had attempted to remove the io with a 10ml syringe without success from the right tibia.The needle was not removed successfully as "the hub pulled off.[the nurse] attempted to grip the piece of the needle extending above the skin and that broke off as well".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that when attempting to remove "an io device, the hub broke free from the needle leaving the needle in the patient's tibia".Additional information states that the bedside nurse had attempted to remove the io with a 10ml syringe without success from the right tibia.The needle was not removed successfully as "the hub pulled off.[the nurse] attempted to grip the piece of the needle extending above the skin and that broke off as well".Additional information received from the customer on (b)(6) 2023 reports "the needle in the right tibia was completely removed with a needle driver after it broke off when trying to remove the io.After removal with the needle driver, xr confirmed there was no residual foreign body.No further intervention at this time".

• Brand Name: EZ IO 25MM 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: 17071257
• Report Number: 3011137372-2023-00154
• Device Sequence Number: 12294539
• Product Code: FMI
• UDI-Device Identifier: 10801902170344
• UDI-Public: 10801902170344
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: IPN917322
• Device Catalogue Number: 9001P-VC-005
• Device Lot Number: UNKNOWN
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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: N/A.; N/A.
• Patient Sex: Unknown